Syllabus A pages 1-120
4/14/98 20:52
Page 36
Abstract: Development of validated and reliable outcome measures for spasticity rehabilitation has been hampered by the difficulty of quantifying functionally important parameters such as pain, ease of care, and mobility. Nonetheless, a combination of measures designed to assess technical and functional outcomes, patient satisfaction, and the cost effectiveness of treatment can be used together to evaluate status and track change in spasticity management, including treatment programs involving botulinum toxin. While double-blind, placebo-controlled studies remain the gold standard for clinical testing, the single-subject design is a useful alternative in many treatment protocols. Because no single tool can measure the many types of changes possible with treatment, the choice of assessment tools must be based on the functional changes expected from the treatment. A wide range of assessment tools are critically reviewed for their sensitivity, reliability, validity, and ease of administration. © 1997 John Wiley & Sons, Inc.Spasticity: Etiology, Evaluation, Management, and the Role of Botulinum Toxin Type A, MF Brin, editor. Muscle Nerve 1997; 20 (suppl 6): S36-S60. Key Words: spasticity, spasticity management, outcome measures, study design, patient-centered scales, botulinum toxin
Outcome Measures in Spasticity Management Susan H. Pierson, MD, PT The development of objective outcome measures in the treatment of spasticity has been driven more by pressures from academic medicine and third-party payers than from within the clinical neurology and rehabilitative medicine settings in which they are intended to be used. Moreover, their transplantation to, and usefulness in, clinical medicine has been limited, particularly for the documentation of non-ordinal data such as “function,” “movement,” and “pain,” where a narrative format is more commonly used to describe a patient’s condition and progress from visit to visit. In recent years, however, an increasing number of voices from within the clinical professions have joined the call for more valid and reproducible scales. Practicing physicians and therapists now have a range of outcome measures from which to choose, with the likelihood that these will be added to and improved on as experience with them increases, and validation studies are performed.
Goal of Measurement The goal of an outcome measure is to allow quantification of physical status and change in a standardized, reproducible way. Measurements can define the severity of the problem, whether change has occurred over time, and whether interventions have had an effect. Standardized measures are designed for a specific purpose in a speci-
fied population, with detailed instruction for administering the measure and interpreting the scores. Results of reliability and validity investigations may be available, which allow comparison against population norms. Developing valid and reliable measures has been particularly difficult in the medical rehabilitation field, because such clinically important measures as strength, spasticity, pain, and function lend themselves poorly to ordinal classification. While laboratory values, vital signs, and other numerical data are far more easily collected and analyzed, their clinical relevance to spasticity is limited.
Definition of Data Type In the measurement of functional outcomes, data can be classified within levels described by Wade.40 Nominal measures group data by category, such as sex and diagnosis. There is no particular order to the data points, nor implied weighting or value difference among them. Ordinal data has some order to it, with scoring weighted in one direction. Virtually all of the measures used to quantify function and most of the scales that quantify movement and spasticity are ordinal. Two types of ordinal measures exist. The first measures a patient’s performance of a specific skill, such as the amount of assistance required to ambulate, and grades it on a simple one dimensional scale (e.g., “min-
Susan H. Pierson, MD, PT Director of Neurorehabilitation Heather Hill Rehabilitation Hospital 12340 Bass Lake Road Chardon, OH 44024
S36
Measures in spasticity management Muscle & Nerve
KEY POINTS
• A wide range of outcome measures exists for assessing spasticity and the effectiveness of intervention • Most spasticity rating scales are ordinal • Equal intervals between units on an ordinal scale cannot be automatically assumed • Non-interval scaling can be addressed using Rasch analysis, though care must be taken to avoid inappropriate extrapolation
Supplement 6 1997
Syllabus A pages 1-120
4/14/98 20:52
Page 37
mod-max”). The second is a multidimensional scale where performance on many items is ranked individually; these scores are then added to give an overall score. The Functional Independence Measure (FIM)39 and Barthel Index26 are examples of this second type. In neither type of scale can one automatically assume equal intervals between scores, however. The difference between 1 and 2 may not be equal in severity or extent of disability to the interval between 6 and 7. Because of this non-interval scaling, such ordinal data is not parametric, meaning it cannot be treated with standard arithmetic processing such as frequency counts and mean calculations. To overcome this deficiency, a probabilistic measurement process such as Rasch analysis18 can be used. This is a mathematical procedure by which the total scores of summed interval data (i.e., ordinal data) are divided in a manner that equalizes the intervals. This allows the points on the scale to be equally spaced and additive. Rasch analysis can also make two different scales exhibit unidimensionality, by manipulation of scores from the different scales which measure similar areas of function. After Rasch analysis is applied, the scores can then be analyzed using parametric processes. The equal intervals, termed “logits,” are devised on the basis of probability, such as the probability that a person with a given level of ability will successfully perform an activity of daily living (ADL) task. Since the person with more ability has a higher probability of succeeding at the task, he is assigned a higher score. The equal intervals of logits lend themselves to extrapolation, and so can compensate for missing data (since they are based on probabilities and not raw scores). Risks of this extrapolation include the misfitting of items within the extrapolated intervals. Misfitting of items may occur if the items on the scale truly don’t fit with the process or skill being measured (such as the placement of affective
items on a cognitive scale). It can also occur if the test items are vaguely worded or open to interpretation. Rasch analysis has been applied to functional rating scales such as the Patient Evaluation and Conference Systems (PECS),22 and to the Assessment of Motor and Performance Skills (AMPS),12 a measure of performance of ADL tasks in occupational therapy. Rasch analysis can be avoided altogether if the original scale is designed with equal intervals between scores. Such “interval scales” are parametric without any manipulation. The Galveston Orientation and Amnesia Test25 is an interval measure with cognitive items weighted by difficulty and spaced evenly, and then summed to a total score. The Sickness Impact Profile (SIP)6 is another interval scale, and one in which the intervals are derived by asking patients to judge the relative value of different data points. With the SIP, “running with difficulty” is given a much higher score than “not walking at all.”
KEY POINTS
• Ratio scales, such as before/after measurements, are useful, reliable, and easy to administer • A technical outcome is an expected change in a measurable variable, based on the technical goals of a procedure
Ratio scales are also used in measuring function and recovery. Any timed test, such as the distance ambulated or the number of pegs placed in 60 seconds, allows the construction of a “before/after” ratio. These are useful and easy to administer in rehabilitation practice and are reliable and reproducible enough to be used in multicenter clinical trials.
Components of Medical Outcomes Goldberg14 suggests that outcomes be evaluated by the following four measures: - Technical accomplishment - Functional outcomes - Patient satisfaction - Cost effectiveness Technical outcomes identify a specific technical goal of a procedure or surgery. It may be the improvement in range of motion follow-
Measures in spasticity management Muscle & Nerve
Supplement 6 1997
S37
Syllabus A pages 1-120
4/14/98 20:52
Page 38
ing adductor tenotomy or the increase in hematocrit after transfusion. Technical outcomes are measured with laboratory instruments such as goniometers, rulers, and radiographs. Functional outcomes focus on what the patient is doing. They measure the patient’s ability to perform a task to completion, and may also measure the quality of the performance, (e.g., ease of movement, normalization of gait pattern). Functional improvements enhance the patient’s or the caregiver’s quality of life, so measures of function can also be measures of quality of life. Patient satisfaction measures require that the patient be queried not only about the outcomes as a result of the intervention or procedure, but also about how that care or intervention was delivered. Patient satisfaction can be measured accurately.23 Lastly, measuring cost effectiveness can be a daunting but necessary task, as medicine reassesses those procedures which are routinely done or those treatments routinely administered. The decision to intervene or not often involves choosing between enhancing the health of the individual and enhancing the health of the community. This dilemma currently faces health care payers, professionals, and legislators. Measuring each of these may involve consideration of multiple factors and require using several independent scales. For instance, ease of caregiving and time dedicated to it are also centrally important outcomes, and caregiver responses should be part of any measure of patient satisfaction. Cosmesis, which may constitute more than physical appearance, can influence affective state, self-esteem, and patient satisfaction. Economic issues, such as the cost of vigorous PT-directed stretching programs, can come into play, and require recognition.
S38
Campbell8 makes the essential point that reliable outcome measures allow not only the provider, but also the patient and family, to determine which interventions are effective for which conditions. Reliable outcome measures are expected to empower consumers to make more informed choices about their health care, give payers standard expectations for return on their investments, and direct health care professionals towards delivering the most potent and appropriate therapies for enhancing function and preventing further disability.
Study Design The “gold standard” for clinical testing of any intervention is the randomized, doubleblind, placebo-controlled trial. While these types of trials are relatively easy to use for short-acting medications such as Sinemet, they can become unwieldy for studies of the efficacy of botulinum toxin (BTX), where data collection must extend over at least 6 months in order to compare outcomes with and without the treatment intervention. Nonetheless, they have been done, as detailed by Simpson.38
KEY POINTS
• A functional outcome is an expected change in a patient's ability to perform a task • Patient satisfaction measures are concerned with both the result and the process of care delivery
The single-subject design offers another model for evaluation and research.4,29 This method was developed during the 1970s to aid assessment of educational interventions in the special needs population. It has not been widely used in general medicine, but has gained some acceptance in the allied health professions, psychology, and rehabilitative medicine.15 In this model, the subject unit is the single patient or a small series of patients. The intervention is the independent variable, and the expected outcome (increased range of motion, decreased spasticity, increased function) is the dependent variable. The outcome measure is administered at repeated intervals and data collected, most appropriately by independent reliable examiners. Comparisons are made within subjects rather than between subjects and so the results apply only to the individ-
Measures in spasticity management Muscle & Nerve
Supplement 6 1997
Syllabus A pages 1-120
4/14/98 20:52
Page 39
ual or subject series. While these results cannot be generalized, generality is said to be achieved through study replication.42 Functional effects of the intervention can be measured by first defining target behaviors (e.g., turning a doorknob to open the door). Where no appropriate validated measures exist, operationally defined measures of behavioral response are developed. Initial pilot data collection can confirm the adequacy of the operational definition (e.g., independently turning a doorknob, maneuvering independently within the household). Operational definition often requires analysis of the targeted behavior and selecting some aspect of it that is most easily measured (e.g., volitional supination) and reliably reproduced. Table 1 outlines the steps that may be useful in study design. The design paradigm may follow an AB or ABA design, depending on whether the aim of the study is to prove functional or technical change with treatment (AB), or to prove gains with treatment and then regression when treatment is withdrawn (ABA).
Test Selection To select a test that measures changes in functional and technical values as a result of treatment, one must first define those mea-
sures that are objective, and ideally, validated and standardized with norms against which patient performance can be compared. Non-normative data, if objective, can at the very least provide evidence of treatment efficacy when the patient is used as his own control or when the outcome being measured is not ordinal. The ideal test will have a well-defined scoring system and known psychometric properties of reliability and sensitivity to change, and be administered using standard instructions.36 Unfortunately, few clinical tests for spasticity are validated in this regard. In addition, the tests chosen should assess a wide range of tasks commonly performed in daily living, and document a continuum of change within each category of function assessed. Finally, the tests must be practical, i.e., easy and timely to administer, using test equipment or materials that are affordable and available. In assessing outcomes in the pediatric population, efficacy measures must also account for the influence of neural maturation and physical growth. They must be able to distinguish those changes due solely to the therapeutic intervention from those due to normal growth and development.
Table 1.
Single-Subject Study Design Define subject unit: single patient or small series Identify independent variable: intervention Identify dependent variable: expected outcome Define target behaviors Choose validated measure, or define measure based on expected response Select easily quantified relevant aspect of target behavior Choose design paradigm: AB or ABA (withdrawal) Begin intervention Collect data: at repeated intervals, by independent examiners Assess outcome: within patient or among small series
Measures in spasticity management Muscle & Nerve
Supplement 6 1997
KEY POINTS
• Few clinical tests for spasticity have been validated • The choice of test must be based on the change expected, and the sensitivity must match the range of expected improvement. Otherwise, the results will be meaningless • The potential for a positive functional outcome following treatment depends on many factors besides spasticity, which must also be accounted for by the chosen outcome measures
S39
Syllabus A pages 1-120
4/14/98 20:52
Page 40
Some general principles can be stated regarding the choice of an appropriate scale. Because multiple variables contribute to outcome, assessment tools should apply to more than just the limb or muscle in question. Further, the choice of scales must be based on the change expected. Without this, no meaningful data can be collected on the effectiveness of the intervention. In addition, the sensitivity range of the test should match the range of improvement expected. The results of some tests will show floor or ceiling effects beyond the narrow limits of their sensitivity, obscuring evidence of functional change that may have occurred. As discussed below, there is no one test that is superior or measures every aspect of spasticity and resultant functional change with intervention. As a result, the set of outcome measures to be used must be selected with a specific purpose in mind. While the use of only one scale may be justified in some clinical situations, more meaningful results will almost always be obtained by use of several different, well-chosen scales.
Spasticity Measurement Focal spasticity can be evaluated with electrodiagnostic tests. Mayer27 emphasizes that polyelectromyographic kinesiology techniques can identify electrical activity in agonist and antagonist muscles during attempted movement. Electromyography (EMG) recordings, even simple dual channel EMG, can define those muscles which are overactive or inappropriately co-contracting during a desired movement. EMG can also identify whether a target muscle is paretic (e.g., wrist extensors in a hemiparetic arm) by analysis of the recruitment pattern on EMG. EMG recordings that are electrically silent during stretch may suggest contracture. Preand posttreatment recordings may be noticeably different from the clinical impression (see Figures 1a and 1b).
S40
Measures in Spasticity Management Clinical rating scales for spasticity have been particularly difficult to develop. Obstacles encountered include not only the heterogeneity of the affected body regions and the variety of circumstances which can change spasticity intensity between evaluations, but also the problem of objectively measuring tone. The intensity and distribution of spasticity may be affected by the time of day, training effect, emotional state of the subject, or concurrent illness. Some of these items can be easily controlled when administering outcome measures, though others cannot. Also, there is a poor correlation between the observed reduction in spasticity and the Figure 1A.
Pretreatment EMG analysis during attempted wrist extension demonstrates pronounced co-contraction of the antagonist wrist flexors. This suggests that co-contraction, rather than agonist (extensor) weakness, is responsible for the impairment in isolated wrist extension. The EMG recording of the wrist extensor activation is not shown. EMG
Measures in spasticity management Muscle & Nerve
Supplement 6 1997
Syllabus A pages 1-120
4/14/98 20:52
Page 41
improvement in function.17,21 Questions inevitably arise: Does change in spasticity not affect function because no effect actually occurs, because the patient was inappropriately selected for spasticity reduction, or because the functional measures used are insensitive or unreliable? Most experienced clinicians can cite many instances in which reducing spasticity improved some aspect of daily function, but only in a task performance specific to the individual. For example, the outcome might be fewer spasms disrupting sleep, or the improved ability to use the affected arm in a helper function like carrying firewood, washing dishes, or grooming a pet. There is an enormous variety of factors that can influence whether a positive functional outcome occurs as a result of spasticity treatment, in addition to the severity and distribution of the spasticity itself. They include such things as the presence of sensory loss or hemi-neglect, visual impairment, postural dyscontrol, underlying weakness, pain, inattention or other cognitive disability, affective dysfunction, and early or overwhelming fatigue. Outcome measures must account for those factors as well. Attempting to improve function by treating only the spasticity can be futile.
Recent efforts by Katz et al.20 have demonstrated some relationship between the subjective clinical assessment of spasticity as measured on the modified Ashworth scale,2 and more objective electrophysiologic and biomechanical measures, such as the Hreflex, ramp and hold, and pendulum tests. These investigators also studied the correlation between these objective measures of spasticity and measurement of motor impairment using the Fugl-Meyer scale.13 Torque and threshold angle measures were recorded in the upper extremity with a device that produces passive movement of the elbow in a horizontal plane. (The threshold angle is defined as the joint angle at which torque, electromyographic, and stretch reflex activity begin to increase in an initially silent passive muscle.) The ratio of the H-reflex to the M response was also colFigure 1B.
Here the posttreatment interference pattern of the antagonist wrist flexors is substantially reduced, following BTX injection into those muscles. This allows the wrist extensors (not shown) to contract without opposition. EMG
Correlation Between Clinical and Objective Measures of Spasticity Truly objective, technical measures of spasticity have been cumbersome, expensive, and limited in their applicability to the clinical environment. Tests such as the threshold angle torque measurements with electrogoniometry34 and electrophysiologic measures such as the H-reflex10 and Vibratory Inhibitory Reflex28 have not gained any widespread use in the clinical setting due to these limitations. Their relevance to the actual clinical state of the patient has not been well demonstrated.
Measures in spasticity management Muscle & Nerve
Supplement 6 1997
S41
Syllabus A pages 1-120
4/14/98 20:52
Page 42
lected on their group of subjects both in the arm and the leg.
Measuring Patient Function and Quality of Life
KEY POINTS
Results in the upper extremity indicated that both the Ashworth and Fugl-Meyer scores correlated significantly with the ramp and hold threshold angle measurement. The Ashworth score was well correlated with the Fugl-Meyer score of upper extremity motor recovery. In the lower extremity, the Ashworth score correlated well with the pendulum test,3 but not with the FuglMeyer score. The investigators confirmed that the objective measures they studied were reproducible, at least among their study population of chronic hemiplegic patients. Interestingly, they found the H/M ratio to be disappointingly variable from subject to subject, and no correlation was seen with the patient’s clinical state.
Global scales of function such as the FIM or the Barthel Index may not be sensitive to changes in the quality of isolated movements, as when botulinum toxin is used to decrease excessive finger flexor spasticity and enhance grasp and release. However, timed tasks of finger and hand dexterity are appropriate when the aim of treatment is to enhance isolated movement in the arm or hand and balance the agonist/antagonist pair. Timed coordination tasks coupled with technical measures such as range of motion, video motion analysis,43 and Ashworth score may confirm a significant clinical effect. Hygiene scores, ease of caregiving scores, the Brace Wear Measure,31 or simply timing tolerance to the brace, may be more appropriate when treatment goals are directed at improving hygiene, pain, or splinting tolerance. If normalization of gait pattern is the goal, timed tests of ambulation, which reflect the increase in cadence and speed of walking, are not only easy to use but are quite sensitive to change and reproducible over serial trials.7
• Changes in technical measures of spasticity may not correlate well with clinical improvement
Priebe et al.35 attempted to correlate results among clinical scales commonly used in measuring spasticity in spinal cord injury patients. Eighty-five subjects were each tested with a variety of clinical measures such as the Penn spasm frequency scale30 and the Ashworth score. They found poor correlation among the various scales, suggesting that each scale assesses a different aspect of spasticity in spinal cord injury. Because there is poor agreement among these scales, the authors recommend a comprehensive set of spasticity assessments be used to evaluate the effect of any treatment. Inclusion of patient satisfaction, global functional scales, and technological assessment are all recommended when pre- and post-testing a patient receiving an intervention for spasticity.
S42
• Because there is poor agreement among clinical spasticity scales, a comprehensive set of tests is needed to evaluate the effects of treatment
Quality of life measures have received increasing attention in the scientific literature. These models incorporate changes in health state and changes in quality of life, such as intolerable side effects of medication. They are designed to evaluate treatment trade-offs, such as temporary immobility after tenotomy vs. improved gait after recovery and rehabilitation. Quality of life dimensions can include relevant aspects of the disease or symptom to be studied. They can be designed to consider the indirect costs or social costs of an illness or disability such as loss of job. Despite the recognition that the patient’s perceptions of disability or change is important to proving the efficacy of the intervention, the quality of life measures thus far developed are statistically cumbersome37 and their validity is not cer-
Measures in spasticity management Muscle & Nerve Supplement 6 1997
Syllabus A pages 1-120
4/14/98 20:52
Page 43
Case History C.P. is a 71-year-old right-handed white female, who suffered a right lacunar stroke with resultant left hemiparesis 12 months earlier. At the time she presented, she was ambulating independently with a quad cane and left ankle foot orthosis (AFO). She required set-up and minimal assistance for upper extremity (UE) bathing and dressing, and moderate assistance to don and doff her shoes and socks. She did not report pain in the UE or hand, but complained of discomfort while wearing her AFO, and she had developed a painful callus over the navicular bone. She ambulated at the household level with her quad cane and left AFO at a slow pace, and her endurance was limited. She complained of a poor AFO fit and an abnormal gait pattern. The patient desired improvement in the position of her left UE during gait because the excessive flexion at the elbow was interfering with her balance, her dressing, and her cosmesis. She also wanted a more normal gait appearance. Clinically, she presented with a spastic hemiplegia with preserved sensation. Her examination revealed no isolated movement on the left. In her left UE, she had some minimal volitional movement, and 3/5 power, in flexor synergy. She had learned to use this movement to help stabilize objects in front of her, to dress, and to grasp objects in the left hand as she manipulated them with her right. She had 3/5 power in synergy in the hip and knee, but no movement of the ankle or foot. The great toe was postured in extension (striatal toe). Spasticity was present at rest and increased further with activity. There were minor limitations in range at the ankle, fingers, wrist flexors, and shoulder. Gait evaluation disclosed a tendency to plantarflex and invert within the brace, and this limited stance time and toe-off on the left. Discussion: This patient may benefit from botulinum toxin type A treatment. Her UE function could be improved by weakening the involved muscles of the elbow and wrist (i.e., the elbow and wrist flexors), while retaining the strength and control of the finger flexors. Her brace tolerance and gait might be improved by weakening the invertors and plantarflexors of the foot along with the great toe extensor (extensor hallucis longus). The treatment plan consisted of 100 U BOTOX速 to the bicep and brachialis; 60 U to the flexor carpi radialis; 45 U to the flexor carpi ulnaris; and 45 U to the pronator teres, in order to improve left UE extension without losing the ability to grasp with the fingers. To improve plantigrade position during stance and fit within the brace, 200 U BOTOX速 were injected into the plantarflexors; 45 U to the extensor hallucis longus; and 45 U to the invertors. Outcome measures were applied as follows: MEASURE
RATIONALE
1. Goniometry
To demonstrate a technical change following BTX-A. Decreased tone allows both increased active and passive range of motion. Enhanced active range of motion may also imply improvement in strength and isolated control. Rest position is also documented both before and after treatment, as BTX may modify that parameter, reflecting improved cosmesis.
2. Ashworth Scale
To demonstrate a technical change following BTX-A. Ashworth is the most universally accepted tone rating scale.
3. Brace Wear Measure To confirm a change in brace fit. Intolerance of her brace was a chief complaint. 4. Ambulation Speed
To show a change in walking speed. One goal of treatment was to normalize gait and reduce energy expenditure.
5. Jebsen Taylor Hand Function Test
To demonstrate improvement in dexterity and isolated finger movement. The patient had some functional grasp, but improper wrist position was interfering with her ability to maximize it.
6. FIM UE Motor Score To demonstrate a change in ADL skills. Global scales are insensitive to isolated tone reduction, but one goal of treatment was to enhance function. 7. Pain Analogue Scale To demonstrate reduction in pain following BTX-A treatment. Pain reduction is an important outcome for those patients with substantial pain, and BTX-A generally will reduce pain due to tone or to poor brace fit. 8. Berg Balance Scale
To demonstrate enhancement in balance following BTX-A. The patient had complained that the excessive flexion of the left arm was throwing off her balance in gait, and the aim of treatment was to reduce this excess flexion. Her inability to achieve normal stance time and toe-off on the paretic side further worsened her balance as well.
Measures in spasticity management Muscle & Nerve
Supplement 6 1997
S43
Syllabus A pages 1-120
4/14/98 20:52
Page 44
MEASURE
RATIONALE
9. COPM
To objectively measure the attainment of the patient’s own goals. The patient had identified several problems in occupational performance prior to treatment. The five parameters most important to the patient were rank-ordered, in terms of the patient’s perceived ability to perform these functions, and in terms of their importance to her. The five parameters were dressing, grooming, functional mobility, self-esteem, and self-confidence. The means of the performance and satisfaction scores before and after treatment are compared. A change of 2 or more points is deemed a significant clinical change.
MEASURE
PRETREATMENT
POSTTREATMENT
1. AROM
Wrist Extension Elbow Extension
-150° -60°
-110° -30°
2. PROM
Wrist Extension Elbow Extension
-20° 0°
0° 0°
3. Rest Postition Wrist Extension Elbow Extension
-150° -70°
-100° -30°
4. Ashworth
3.5 3.0
2.0 1.0
5. Brace Wear Measure
Unable to Tolerate
Brace Fit Proper
6. Ambulation Speed
39 sec
25 sec
7. Jebsen Hand Test Writing Card Turning Small Common Objects Simulated Feeding Checkers Large Light Object Large Heavy Object
Unable 12 sec 25 sec 36 sec 23 sec Unable Unable
Unable 7 sec 18 sec 30 sec 20 sec Unable Unable
8. FIM UE Motor Score
8/16
12/16
9. FIM Mobility Score
10/20
13/20
10. Pain Analogue Scale
6
0
11. Berg Balance Scale
28/56
35/56
12. COPM Mean performance score Mean satisfaction score
1.8 2.0
5.0 Change (3.2) 7.2 Change (5.2)
Wrist Flexors Elbow Flexors
Note regarding single subject study design: Any case similar to this could be used as part of a single-subject study with BTX-A. Each of the above outcome measures would be completed pretreatment and then again at appropriate intervals following treatment. Interval selection might include 2 weeks posttreatment, to assess for adverse effect and functional worsening, 4 weeks posttreatment to address the reduction in spasticity when it is theoretically at its greatest, and again at 3 and 6 months to assess the length of benefit: technically, functionally, and in terms of patient satisfaction.
S44
Measures in spasticity management
Muscle & Nerve Supplement 6 1997
Syllabus A pages 1-120
4/14/98 20:52
Page 45
tain when applied to diverse disorders.41 Controversy exists as to whether one can even define quality of life, let alone measure it reliably. The scales that have been validated assess a wide range of health issues and are widely used. These include the SF-3637a and the SIP. However, neither has been documented to be specific in the stroke population.16 Simpler measures of patient perception of disability, change, and satisfaction with treatment effect are available but not widely used in clinical trials (e.g., the Function and Pain Assessment Scale1).
Patient Satisfaction and the Role of Patient-Centered Scales While measuring patient satisfaction is vitally important, it can be extremely difficult, particularly in a cognitively impaired patient or during catastrophic disease episodes where patient adjustment issues are important but usually uncontrollable variables. Nonetheless, attending to patient satisfaction offers several advantages.11 It can educate clinicians to better understand the patient’s expectations and perception of the service received. It can provide information regarding the patient’s use of health care services and health-related behaviors such as “doctor-shopping.” Finally, the opportunity for a patient to provide feedback about his perception of treatment success can enhance the patient’s compliance with his treatment regimen, provide an important benchmark for continuous quality improvement (CQI) programs, and direct attention to the delivery of the service as well as to the service itself.
ronmental and social factors that influence observed behavior. It is an individualized scale that is not diagnosis-specific, and crosses developmental stages. The COPM assesses client outcomes in the areas of self-care, economic productivity, and leisure pursuits, using a patient-centered process to identify problems in functional performance, define treatment goals, and assess progress. It includes a five-step process based on a semi-structured interview with the patient or caregiver. The process includes occupational performance problem identification; problem weighting based on the patient’s (not the examiner’s) concerns; ranking of the five most urgent problems; reassessment after treatment; and follow-up to plan for further treatment or discontinuation of treatment.32,33 This patient-centered assessment and reassessment process provides a standardized format to detect the individual’s self-perceived change in occupational performance problems over time. The COPM is both an assessment tool and an outcome measure that can be used in the context of a singlesubject design paradigm. It has demonstrated test-retest reliability and has been validated for its responsiveness to change. Thus, it can be used as a patient satisfaction measure for randomized trials as well. It is a standardized instrument in the sense that there are specific instructions and methods for administering and scoring the test, but it is not a norm-referenced tool.5,24
KEY POINTS • The COPM is a useful measure for tracking both functional changes and patient satisfaction
Standards for the Use of Measures
The Canadian Occupational Performance Measure (COPM)33 has proved to be a very useful tool for tracking both functional changes and patient satisfaction following spasticity treatments. Designed by the Canadian Association of Occupational Therapists, the COPM attempts to take into account the unique needs, goals, and abilities of the individual patient, and the envi-
In summary, validated outcome measures should be used wherever possible and are the foundation of well-designed clinical trials. Even in office practice, certain standards should be adhered to in the administration and interpretation of those measures. General standards for the use of measure have been defined19 and are briefly summarized in Table 2.
Measures in spasticity management
Muscle & Nerve Supplement 6 1997
S45
Syllabus A pages 1-120
4/14/98 20:52
Page 46
Table 2.
Standards For The Use of Outcome Measures 1. Users should be familiar with all relevant administration, scoring, and interpretation procedures 2. Users should understand the validity and reliability basis of the measure they select 3. The measure used should be relevant to the clinical situation, the population being measured, and the decision-making process 4. Potential harm to the subject (either psychological or physical) should be considered and the risk-benefit ratio determined 5. Appropriate test conditions and procedure should be adhered to if outcome data is to be compared to published data and documented reliability, validity, and normal values 6. The sensitivity, specificity, pretest probability, and prognostic validity of the tests that categorize or diagnose the person being tested should be considered 7. If the tests do not meet the standards used, caution and reservation regarding results should be considered 8. Measurement selection must consider practicality in terms of personnel, time, equipment, cost, space, and impact on the subject.
Following the bibliography, a list of measures is presented that have been selected for their relevance to measuring status and change in patients receiving treatment for spasticity. The list is extensive but by no means comprehensive. Specificity and sensitivity in measuring technical and functional change relative to spasticity management is the goal but cannot be guaranteed. Each measure is categorized, briefly described, and referenced.
Suggested Readings for Measurement in Neurological Rehabilitation 1. Jones EW, Mulley GP: The measurement of spasticity, in Rose FC (ed): Advances in Stroke Therapy. New York, Raven Press, 1982. 2. Cole B, Finch E, Gowland C, Mayo N: Physical Rehabilitation Outcome Measures. Baltimore, Williams & Wilkins, 1995. 3. Wade DT: Measurement in Neurologic Rehabilitation. New York, Oxford Medical Publications, 1992.
S46
Measures in spasticity management Muscle & Nerve Supplement 6 1997
Syllabus A pages 1-120
4/14/98 20:52
Page 47
Bibliography 1. Allergan, Irvine, CA. Function and Pain Assessment Scale. Upper Extremity Spasticity Study Following Stroke, BOTOX Study. 133-8051. 1997 2. Ashworth B: Preliminary trial of Carisprodol in multiple sclerosis. Practitioner 1964; 192:540. 3. Bajd T, Vodovnik L: Pendulum testing of spasticity. J Biomed Eng 1984; 6:9-16. 4. Barlow DH, Hersen M: Single Case Experimental Designs: Strategies for Studying Behavioral Change. Boston, Allyn & Bacon, 1995. 5. Barry MJ, Albright LA: Use of the Canadian Occupational Performance Measure for intrathecal baclofen therapy. Pediatric Phys Ther 1996; 8:183. 6. Bergner M, Bobbitt RA, Carter WB, Gilson BS: The Sickness Impact Profile: development and final revision of a health status measure. Med Care 1981;19:787-805. 7. Brandstater ME, de Bruin H, Gowland C, Clark BM: Hemiplegic gait: analysis of temporal variables. Arch Phys Med Rehabil 1983; 64:583-587. 8. Campbell SK: Quantifying the effects of interventions for movement disorders resulting from cerebral palsy. J Child Neurol 1996; 11 (Suppl 1):S6170. 9. Campbell SK (ed): Physical Therapy for Children. Philadelphia, WB Saunders, 1994. 10. Delwaide PJ: Human reflex studies for understanding the motor system. Phys Med Rehabil Clin North Am 1993; 4:669-686. 11. Elliot-Burke TL, Pothast L: Measuring patient satisfaction in an outpatient orthopedic setting, part I: key drivers and results. J Rehabil Outcomes Measurement 1997; 1:18-25.
13. Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S: The post-stroke hemiplegic patient. I. A method for evaluation of physical performance. Scand J Rehabil Med 1975; 7:13-31. 14. Goldberg MJ: Measuring outcomes in cerebral palsy. J Pediatr Orthop 1991; 11:682-685. 15. Gonnella C: Single-subject experimental paradigm as a clinical decision tool. Phys Ther 1989; 69:601-609. 16. Gresham G (ed): Assessment methods for patients with strokes, in Post-Stroke Rehabilitation Guidelines. Clinical Practice Guideline #16. U.S. Department of Health and Human Services, 1995, pp 33-51. 17. Haas BH, Crow JL: Towards a clinical measurement of spasticity? Physiotherapy 1995; 81:474479. 18. Harvey RF, Jellinek HM: Functional performance assessment: a program approach. Arch Phys Med Rehabil 1981; 62:456-460. 19. Johnston MV, Keith RA, Hinderer SR: Measurement standard for interdisciplinary medical rehabilitation. Arch Phys Med Rehabil 1992; 73:s3-s23. 20. Katz RT, Rovai GP, Brait C, Rymer WZ: Objective quantification of spastic hypertonia: correlation with clinical findings. Arch Phys Med Rehabil 1992; 73:339-347. 21. Katz RT, Rymer WZ: Spastic hypertonia: mechanisms and measurement. Arch Phys Med Rehabil 1989; 70:144-155. 22. Kilgore KM, Fisher WP, Silverstein B, Harley JP, Harvey RF: Application of Rasch analysis to studies in occupational therapy. Phys Med Rehabil Clin North Am 1981; 62:456-461.
12. Fisher WP, Fisher AG: Applications of Rasch analysis to studies in occupational therapy. Phys Med Rehabil Clin North Am 1993; 4:493526.
Measures in spasticity management Muscle & Nerve Supplement 6 1997
S47
Syllabus A pages 1-120
4/14/98 20:52
Page 48
23. Lavies AR, Ware JE: Involving consumers in quality care assessment. Health Aff 1988; 33-48. 24. Law M, Baptiste S, Carswell A, McCall MA, Polatajko H, Pollack N: Canadian Occupational Performance Measure Test Manual. Toronto, CAOT Publications, 1994. 25. Levin HS, O'Donnell VM, Grossman RG: The Galveston Orientation and Amnesia Test. A practical scale to assess cognition after head injury. J Nerv Ment Dis 1979; 167:675-684. 26. Mahoney F, Barthel D: Functional evaluation: the Barthel Index. Maryland State Med J 1965; 14:6165. 27. Mayer NH: Functional management in spasticity after head injury. J Neuro Rehab 1991; 5:1-11. 28. Nance PW, Shears AH, Nance DM: Reflex changes induced by clonidine in spinal cord injured patients. Paraplegic 1989; 27:296-301. 29. Ottenbacher KJ: Clinically relevant designs for rehabilitation research: the idiographic model. Am J Phys Med Rehabil 1990; 69:286-292. 30. Penn RD, Savoy SM, Corcos DM, Latash, Gottlieb G: Intrathecal baclofen for severe spinal spasticity: a double-blind crossover study. N Engl J Med 1989; 320:1517-1521. 31. Pierson SH, Katz DI, Tarsy D: Botulinum toxin A in the treatment of spasticity: functional implications and patient selection. Arch Phys Med Rehabil 1996; 77:717-721. 32. Pollock N: Client-centered assessment. Am J Occup Ther 1993; 47:298-301. 33. Pollock N, Baptiste S, Law M, Opzoomer A, et al: Occupational performance measures: a review based on the guidelines for client-centered practice of occupational therapy. Can J Occup Ther 1990; 57:77-81.
S48
34. Powers RK, Marder-Meyer J, Rymer WZ: Quantitative relations between hypertonia and stretch reflex threshold in spastic hemiparesis. Ann Neurol 1988; 23:115-124. 35. Priebe MM, Sherwood AM, Thornby JI, Kharas NF, Markowski J: Clinical assessment of spasticity in spinal cord injury: a multidimensional problem. Arch Phys Med Rehabil 1996; 77:713-716. 36. Cole B, Finch E, Gowland C, Mayo N (eds): Physical Rehabilitation Outcome Measures. Baltimore, Williams & Wilkins, 1995. 37. Schwartz CE, Cole BF, Gelber RD: Measuring patient-centered outcomes in neurologic disease: extending the q-twist method. Arch Neurol 1995; 52:754-762. 37a. SF-36 Health Survey, copyright 1992 Medical Outcome Trust, 20 Park Plaza, Suite 1014, Boston, MA, 02116-4313. 38. Simpson DM: Clinical trials of botulinum toxin in the treatment of spasticity. Muscle Nerve 1997; 20 (suppl 6): S169-S175. 39. Guide for the Uniform Data Set for Medical Rehabilitation, Version 4.0 (Adult FIM). State University of New York, Buffalo. UB Foundation Activities, Inc., 1993. 40. Wade DT: Measurement and Assessment: What and Why? in Measurement in Neurological Rehabilitation. Oxford, Oxford University Press, 1992, pp 15-26. 41. Wade DT: Handicap and Quality of Life, in Measurement in Neurological Rehabilitation. Oxford, Oxford University Press, 1992, pp 89-96. 42. Whyte J: Toward a methodology for rehabilitation research. Am J Phys Med Rehabil 1994; 73:428435. 43. Winter DA: Use of kinetic analyses in the diagnostics of pathological gait. Physiotherapy (Canada) 1981; 209-214.
Measures in spasticity management
Muscle & Nerve Supplement 6 1997
Syllabus A pages 1-120
4/14/98 20:52
Page 49
Scales for Adult Patients I. TONE INTENSITY SCALES Name: The Ashworth Scale Description: Ordinal scale of tone intensity 0 to 4; reproducible, proven reliable only at the elbow; patient and test condition variability contribute to unreliability. The Modified Ashworth Scale described by Bohannon and Smith was developed to further define the lower end of the scale, making it more discrete by adding the grade “1+”. References: Ashworth B: Preliminary trial of carisprodol in multiple sclerosis. Practitioner 1964; 192: 540-542. Lee KC, Carson L, Kinnin E, Patterson V: The ashworth scale: a reliable and reproducible method of measuring spasticity. J Neuro Rehab 1989; 3:205-209. Bohannon RW, Smith MB: Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther 1986, 67:206-207.
Name: Degree of Adductor Muscle Tone Description: Ordinal rating of tone in a specific muscle group (hip adductors); appropriate for patients whose treatment is aimed at reducing the adducted leg position. Reference: Snow BJ, Tsui JKC, Bhart MH, Varelas M, Hashimoto SA, Calne DB: Treatment of spasticity with botulinum toxin: a double blind study. Ann Neurol 1990; 28: 512-515. Name: Unified Parkinson's Disease Rating Scale: Motor Subscale Description: Ordinal scale of rigidity, finger taps, rapid alternating movements of the hands, ADLs, etc. It has five sections, all tested for reliability. The motor exam can be given independently and scored serially to assess change after treatment. Reference: Fahn S, Elton RL, Members of the UPDRS Development Committee, in Koller WC (ed): Handbook of Parkinson’s Disease. New York, Marcel Dekker, 1994.
Name: Oswestry Scale of Grading Description: Ordinal scale that rates stage and distribution of tone, quality of isolated movements. Function is addressed by a generalized grade of either useful or nonuseful movement. The scale also attempts to consider the influence of posture and descending brainstem and spinal reflexes on tone. Reference: Goff B: Grading of spasticity and its effect on voluntary movement. Physiotherapy 1976; 62: 358-361.
Measures in spasticity management Muscle & Nerve Supplement 6 1997
S49
Syllabus A pages 1-120
4/14/98 20:52
Page 50
Name: Tardieu Scale Description: An ordinal rating of tone that measures the intensity of the muscle reaction at specified velocities (slowest to as fast as possible). The angle at which the catch is first felt is also noted as a clinical estimate similar to the threshold angle. The three variables are considered simultaneously when assessing spasticity. Correlation with objective measures is not known, but it has been validated in reference to the Ashworth score. References: Tardieu G, Shentoub S, Delarue R: À la d’une techique de mesure de la spasticité, in Held JP, Pierrot-Deseilligny E (eds): Rééducation Motrice des Affections Neurologiques. Paris, JB Baillière et Fils, 1969, pp 31-42. Tardieu G, Rondot P, Dalloz JC, MenschDechenne J, Monfraix C: The stretch reflex in man: a study of electromyography and dynamometry (strain gauge) contribution to classification of the various types of hypertonus, C.P. Cerebral Palsy Bull 1959; 7: 1417.
Name: Spasm Frequency Score Description: Ordinal ranking of spasm frequency per day, rather than per hour. Reference: Snow BJ, Tsui JKC, Bhart MH, Varelas M, Hashimoto SA, Calne DB: Treatment of spasticity with botulinum toxin: a double blind study. Ann Neurol 1990; 28: 512-515.
III. GLOBAL SCALES OF MOTOR IMPAIRMENT Name: Brunnstrom Stroke Scale Description: Qualitative description of stages of motor recovery following stroke. Cumbersome and too complicated to administer according to Wade,40 who suggests other simpler, more sensitive scales. Reference: Brunnstrom S: Movement Therapy in Hemiplegia. New York, Harper and Row, 1970.
II. TONE/SPASM FREQUENCY SCORES Name: Penn Spasm Frequency Score Description: Ordinal rank order scale of spasm frequency used to rate frequency of leg spasms per hour in spinal cord spasticity. Easily scored, based on patient report of spasm activity. Reference: Penn RD, Savoy SM, Corcos D, Latash M, Gottlieb G, et al: Intrathecal baclofen for severe spinal spasticity. N Engl J Med 1989; 320: 1517-1554.
S50
Measures in spasticity management Muscle & Nerve Supplement 6 1997
Syllabus A pages 1-120
4/14/98 20:52
Page 51
Name: Fugl-Meyer Evaluation of Physical Performance Description: Quantification of motor recovery stages based on the scales of Brunnstrom and Twitchell (ontogenetic concept of motor recovery). In addition to motor recovery, balance, sensation, range of motion, and pain are also assessed. Movement is examined in and out of synergies. The scale does not reflect functional use of the extremity, only motor impairment and recovery stage. This scale is commonly used in clinical trials and requires an experienced therapist to administer. References: Fugl-Meyer AR, Jaasko I, Leyman I, Olssom S, Steglind S: The post-stroke hemiplegic patient I. A method for evaluation of physical performance. Scand J Rehab Med 1975; 7: 13-31. Sanford J, Moreland J, Swanson LR, Stratford PW, Gowland C: Reliability of the Fugl-Meyer assessment for testing motor performance in patients following stroke. Phys Ther 1993; 73: 447-454. Name: Rivermead Stroke Assessment Description: Interval scale of motor performance in post-stroke patients dealing with gross motor, leg, trunk, and arm movements. This scale mixes impairment measures with disability measures, but has good reliability and validity. However, it is lengthy to administer and is unwieldy for routine use. Reference: Lincoln N, Leadbitter D: Assessment of motor function in stroke patients. Physiotherapy 1979; 65: 48-51.
Name: Scandinavian Stroke Scale Description: Ordinal scale of impairment divided into several subsets of recovery which grade strength, gait, cognition, attention, and language. Items of prognostic significance are highlighted. Specific items may or may not be sensitive to changes after spasticity treatment. Reference: Scandinavian Stroke Study Group: Multicenter trial of hemodilution in ischemic stroke. Background and study protocol. Stroke 1985; 16: 885-890. Name: Toronto Stroke Scale Description: A reliable and quick-scoring test that primarily measures cognitive and motor domains. Likely to be insensitive to changes brought about by focal spasticity treatment. It is responsive to global change and recovery and can quantify stages of neurologic recovery following stroke. Useful for stratifying patients by stage of motor recovery or extent of motor function. Reference: Cote R, Battista RN, Wolfson C, Boucher J, Adam J, Hachinski V: The Canadian Neurological Scale: validation and reliability assessment. Neurology 1989; 39: 638-643. Name: Motricity Index and Trunk Control Test Description: Simple short measures of motor loss that pertain primarily to hemiplegia following stroke. They can be useful for any upper motor neuron patient. Validity and reliability are proven. Sensitive to motor changes after CVA, although they may not be able to detect changes after focal chemodenervation. Reference: Wade DT, Langton Hewer R: Functional abilities after stroke: measurement, natural history, and prognosis. J Neurol, Neurosurg Psychiatry 1987; 50: 177-182.
Measures in spasticity management Muscle & Nerve Supplement 6 1997
S51
Syllabus A pages 1-120
4/14/98 20:52
Page 52
IV. UPPER EXTREMITY DEXTERITY AND STRENGTH TESTING Name: Grasp Dynamometer Testing Description: Objective instrument that measures grasp strength in pounds, according to the various grasps and pinches. Reference: Trombly CA, Scott AD: Evaluation and treatment of hand function, in Occupational Therapy for Physical Dysfunction. Baltimore, Williams & Wilkins, 1977. Name: Manual Muscle Testing Description: Uses a 6-point grading system to assess strength in muscles where the patient has selective joint control. Strength is rated from 0 (no contractile ability) to 5 (strength through the full range of motion with maximum resistance). Reference: Hislop HJ, Montgomery J: Daniels’ and Worthingham’s Muscle Testing: Techniques of Manual Examination, 6th edition. Philadelphia, WB Saunders, 1995. Name: The Tufts Assessment of Motor Performance (TAMP) Description: Evaluates fine motor skills such as grasp and release, use of fasteners, and object manipulation activities. It has shown good interrater reliability. Selected areas of the TAMP may be used to assess other aspects of activities of daily living including bed mobility and wheelchair skills. Reference: Gans BM, Haley S, Hallenborg S, et al: Description and inter-observer reliability of the Tufts Assessment of Motor Performance. Am J Phys Med Rehab 1988, 67:202-210.
S52
Name: The Purdue Pegboard Test Description: A timed test of finger dexterity in two types of activity: one involving gross movements of the hand, fingers, and arm, and a second involving fingertip dexterity as in small assembly work. Recommended as a routine measure of dexterity. It requires standard prefabricated equipment to administer. It has been validated and is reliable, and has been used in numerous clinical trials of pyramidal and extrapyramidal motor dysfunction. It is portable and brief, but is useless when impairment is severe. Reference: Tiffin J, Asher EJ: The Purdue Pegboard: norms and studies of reliability and validity. J Applied Psychol 1948; 32: 234-247. Distributed by Science Research Associates, 228 S. Wabash, Chicago, IL 60641. Name: The 9-Hole Peg Test Description: This is a simpler and more time-efficient measure of finger dexterity, and can be more applicable to neurologically involved patients. The test requires a patient to place nine pegs into a board and then remove them individually with one hand. This a timed test for which normative data has been obtained. References: Kellor M, Frost J, et al: Hand strength and dexterity. Am J Occup Ther 1971, 25:77-83. Mathiowetz V, Weber K, Kashman N, Volland G. Adult norms for the nine hole peg test of finger dexterity. Occup Ther J Res 1985, 5:24-38.
Measures in spasticity management Muscle & Nerve Supplement 6 1997
Syllabus A pages 1-120
4/14/98 20:52
Page 53
Name: Jebsen Taylor Hand Function Test Description: Timed performance of seven test items designed to represent various aspects of hand function. It has been validated and standardized and is easy to perform in approximately 15 minutes for both hands. Potentially sensitive to changes brought about by spasticity treatment, but only applicable to hands with preserved isolated finger control. Reference: Jebsen RH, Taylor N, Trieschemann RB, et al.: Objective and standardized test of hand function. Arch Phys Med Rehabil 1971; 50: 311-319. Name: Frenchay Arm Test Description: Five test items are scored in a pass/fail fashion. It is valid and reliable, inexpensive, but unlikely to be useful in evaluating any but high-end performance of upper extremity function. Sensitivity is acceptable for research, though patients tend to either completely pass or completely fail every test item. Reference: DeSouza LH, Langton Hewer R, Miller S: Assessment of recovery of arm control in hemiplegic stroke patients. Int Rehabil Med 1980; 2: 3-9.
V. ADL/HYGIENE SCALES Name: Barthel ADL Index Description: Subset of the Barthel Index. Best known and most widely used index. Reference: Mahoney FI, Barthel DW: Functional evaluation: the Barthel Index. Maryland State Med J 1965; 14:61-65.
Measures in spasticity management
VI. CLINICAL GAIT SCORES Name: Timed Ambulation Description: Temporal distance gait measure shown to be sensitive to change; valid and reproducible Reference: Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker, L: Clinical gait assessment in the neurologically impaired: reliability and meaningfulness. Phys Ther 1984; 64:35-40. Name: Timed Up and Go Test Description: Multiphased timed task in which subject is asked to arise from a chair, walk, turn around, and sit down. It is simple, responsiveness is not known, but it is reliable and has been validated and correlated with performance on the Barthel Index and Berg Balance Scale. Reference: Podsiallo D, Richardson S: The timed “up and go�: a test of basic functional mobility for elderly frail persons. J Am Geriatrics Soc 1991; 39:142-148. Name: Ambulation Index Description: Ordinal scale of ambulation distance, speed, and level of assistance needed; developed for the multiple sclerosis population. Familiar to many neurologists. Unlikely to be sensitive to changes brought about by focal spasticity treatment. Reference: Hauser SL, Dawson DM, Lehrich JR, Beal MF, Kevy SV, et al: Intensive immunosuppression in progressive multiple sclerosis: a randomized, three-arm study of high dose intravenous cyclophosphamide, plasma exchange, and ACTH. N Engl J Med 1983; 308:173-180.
Muscle & Nerve Supplement 6 1997
S53
Syllabus A pages 1-120
4/14/98 20:52
Page 54
Name: Functional Ambulation Classification Description: Nominal scale of ambulation dependence/independence grading amount of assistance necessary to ambulate. Easy to administer, sensitive to change. Reference: Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker, L: Clinical gait assessment in the neurologically impaired: reliability and meaningfulness. Phys Ther 1984; 64:35-40.
Name: Hygiene Score Description: Ordinal scale of dependence by patient on others for perineal hygiene needs, primarily reflecting degree of adductor tone. Reference: Snow BJ, Tsui JKC, Bhart MH, Varelas M, Hashimoto SA, Calne DB: Treatment of spasticity with botulinum toxin: a double blind study. Ann Neurol 1990; 28: 512-515.
Name: Berg Balance Scale Description: An ordinal scale of balance that is well validated and reliable. It is sensitive to change and has been comprehensively evaluated in stroke patients in particular. It is straightforward to administer, requiring less than 10 minutes. Reference: Berg K, Wood-Danphinee S, Williams JI, Maki B: Measuring balance in the elderly: validation of an instrument. Can J Public Health 1992; Jul-Aug Suppl 2:S7-11.
Name: Brace Wear Measure Description: Ordinal scale that addresses whether or not the orthotic is properly fitted or even necessary relative to the presence or absence of spasticity. Not validated. Sensitive to changes induced by spasticity treatment. Reference: Pierson SH, Katz DI, Tarsy D: Botulinum A toxin in the treatment of spasticity: functional implications and patient screening. Arch Phys Med Rehabil 1996; 77: 717-721.
VII. PAIN SCALES
VIII. GONIOMETRY
Name: Pain Intensity Descriptor Scale Description: Patient self-administered rating of pain intensity; 13-point scale ranging from no pain to extremely intense. Reference: Gracely RH, McGrath P, Dubner R: Rating scales of sensory and affective verbal pain descriptors. Pain 1978; 5:5-18.
Name: The clinical measurement of joint motion Description: The techniques of goniometry as described in the Handbook of the American Academy of Orthopedic Surgeons. Reference: Greene WB, Heckman JD (eds): The Clinical Measurement of Joint Motion. American Academy of Orthopaedic Surgeons. Rosemont, Illinois. 1994.
Name: Function and Pain Assessment Scale Description: Physician and patient subjective ratings of functional disability, pain frequency and intensity. Reference: Measurement tool in the Allergan Upper Extremity Spasticity Study Following Stroke (BTOX-133-8051).
S54
Measures in spasticity management
Muscle & Nerve Supplement 6 1997
Syllabus A pages 1-120
4/14/98 20:52
Page 55
IX. ELECTROPHYSIOLOGIC/ BIOMECHANICAL MEASURES (Note: These measurements are generally too cumbersome for clinical practice and are best reserved for laboratory testing. Their clinical correlation is not known.) Name: Pendulum Testing of Spasticity Description: A quantifiable evaluation of spasticity that requires the use of an electrogoniometer and tachometer; useful in the clinical environment. Applicable to knee and elbow measurement only. Reference: Bajd T, Vodovnik L: Pendulum testing of spasticity. J Biomed Eng 1984; 6:9-16. Name: Dual Channel EMG Evaluation of Interference Patterns Description: Objective assessment of interference patterns, degree of impaired motor activity produced by paretic muscle, and timing of co-contraction by the antagonist. References: Kraft GH: Hemiplegia: evaluation and rehabilitation of motor control disorders. Phys Med Rehabil Clin North Am 1993; 4:687-705. Keenan MA, Romanelli RR, Lunsford BR: The use of dynamic electromyography to evaluate motor control in the hands of adults who have spasticity caused by brain injury. J Bone and Joint Surg 1989;71-A:120126.
Name: H-Reflex and Hmax/Mmax Ratio Description: EMG measures of the excitability of resting motor neurons in spasticity. Not well correlated with clinical measures of spasticity such as the Ashworth scale. Reference: Delwaide PJ: Human reflex studies for understanding the motor system. Phys Med Rehabil Clin North Am 1993; 4:669-686. Name: Vibration Inhibitory Index Description: Use of vibration to inhibit the H-reflex to derive a score called the Vibratory Inhibitory Index, which is a measure of spasticity intensity. Reference: Nance PW, Shears AH: Reflex changes induced by clonidine in spinal cord injured patients. Paraplegia 1989; 27:296-301.
X. GLOBAL SCALES OF DISABILITY Name: Functional Independence Measure (FIM) Description: Ordinal scale of function in multiple areas, including feeding, grooming, bathing, dressing, toileting, transfers, locomotion, comprehension, expression, social interaction, and problem solving. Reference: Guide for the Uniform Data Set for Medical Rehabilitation (Adult (FIM) Version 4.0). Buffalo, New York; State University of New York, Buffalo/ U.B. Foundation Activities Inc. 1993. Name: Barthel Index Description: Ordinal scale of function in 10 areas similar to the FIM encompassing mobility, ADL function, continence. Reference: Mahoney FI, Barthel, DW: Functional evaluation: the Barthel Index. Maryland State Med J 1965; 14:61-65.
Measures in spasticity management
Muscle & Nerve Supplement 6 1997
S55
Syllabus A pages 1-120
4/14/98 20:52
Page 56
Name: OPCS Disability Scale Description: Ordinal scale of 10 different disability measures, each weighted so that different disabilities can be compared. There is a pediatric version. Not well validated, but comprehensive and easy to grade. References: Martin J, Meltzer H, Elliot D: The prevalence of disability amongst adults, in Office of Population Census and Surveys, HMSO, London. Wade DT: Measurement in Neurologic Rehabilitation. Oxford, Oxford Medical Publications, 1992, pp 196-205.
XI. PATIENT/CAREGIVER ASSESSMENT/REPORT OF ADJUSTMENT AND DISABILITY (“QUALITY OF LIFE” MEASURES) Name: Sickness Impact Profile Description: Interval scale which is a global measure of function. It gives a weighted score to each item in 12 subsections of function, is lengthy (30 minutes), can be completed by the patient/caregiver or in face-to-face interview. There is no well documented responsiveness to change in stroke patients. Subsections may be used alone. Reference: Bergner M, Bobbitt RA, Carter WB, Gilson BS: The Sickness Impact Profile: development and final revision of a health status measure. Med Care 1981; 19:787-805.
S56
Name: SF-36 Health Survey Description: 36-item patient report regarding patient’s perception of health and physical limitations, subscores are weighted in an interval style. It is brief and can be administered by phone, face-to-face with patient, or completed by patient. It does have possible floor effects and may not adequately measure patients with severe disabilities. All items are standardized and it is widely used in the U.S. Reference: SF-36 Health Survey, copyright 1992 Medical Outcome Trust, 20 Park Plaza, Suite 1014, Boston, MA, 02116-4313. Name: Caregiver Dependency Scale Description: Patient report regarding the amount of caregiver assistance required on a typical day. Reference: Environmental Status Scale, Question 4, Minimal Record of Disability for Multiple Sclerosis, p. 44; copyright 1985 National Multiple Sclerosis Society. Name: Canadian Occupational Performance Measure Description: Individualized, client-centered measure of three areas: self-care, productivity, and leisure. The process involves patient interview to define goals and weight them as to their urgency. Includes follow-up assessment after therapy or treatment is complete. Reference: Pollock N, Baptiste S, Law M, McColl MA, Opzoomer A, et al: Occupational performance measures: a review based on the guidelines for client-centered practice of occupational therapy. Can J Occup Ther 1990; 57: 77-81.
Measures in spasticity management
Muscle & Nerve Supplement 6 1997
Syllabus A pages 1-120
4/14/98 20:52
Page 57
Scales for Pediatric Patients I. TESTS OF MOTOR DEVELOPMENT AND FUNCTIONAL PERFORMANCE The following tests use motor milestone and functional performance to document a child’s developmental level in relation to age norms and to document functional limitations that may be present. Name: Alberta Infant Motor Scale (AIMS) Description: Assesses gross motor maturation. Appropriate from birth through the stage of independent walking. Composed of 58 items in four physical positions: supine, prone, sitting, and standing. Requires 15 minutes to administer and is noninvasive; only observation is involved. References: Piper MC, Darrah J: Motor Assessment of the Developing Infant. Philadelphia, WB Saunders, 1994. Piper MC, Pinnell LE, Darrah J, Maguire T, Byrne PJ: Construction and validation of the Albert Infant Motor Scale (AIMS). Can J Public Health 1992; 83(Suppl 2):S46-S50. Name: Miller First Step (Screening Test for Evaluating Preschoolers) Description: Assesses cognitive, communicative, physical, social-emotional, and adaptive function; appropriate from age 2 years 9 months to 6 years 2 months. Evaluates function by performance on games using toys. Requires about 15 minutes to administer. Reference: Miller LJ: The Miller First Step (Screening Test for Evaluating Preschoolers). New York, Psychological Corporation, 1992.
Name: Denver II Description: A revision of the Denver Developmental Screening Test (DDST). Can be used from ages 1 week to 6 years. Includes 125 items in four domains: personal-social, fine motor-adaptive, language, and gross motor. Requires 25 minutes to administer. It has a high sensitivity but low specificity and a high over-referral rate. Reference: Glascoe FP, Byrne KE, Ashford LG, Johnson KL, Chang B, Strickland B: Accuracy of the Denver-II in developmental screening. Pediatrics 1992; 89:1221-1225. Name: Bayley Infant Neurodevelopmental Screen (BINS) Description: This test has no direct relationship to the Bayley Scales of Infant Development. Assesses brain-behavior relationships in the context of developmental change and maturation, in infants from 3 to 24 months. Requires 15 minutes to administer. Reference: Aylward GP. Bayley Infant Neurodevelopmental Screen Manual. San Antonio, TX, Psychological Corporation, 1992. Name: Harris Infant Neuromotor Test (HINT) Description: Detects early signs of cognitive and neuromotor delays in infants with known risk factors, from 3 to 12 months. Requires less than 30 minutes to administer. Reference: Harris SR, Daniels LE: Content validity of the Harris Infant Neuromotor Test. Phys Ther 1996; 76(7):727-737.
Measures in spasticity management Muscle & Nerve Supplement 6 1997
S57
Syllabus A pages 1-120
4/14/98 20:52
Page 58
II. COMPREHENSIVE DIAGNOSTIC DEVELOPMENTAL ASSESSMENTS Name: Bayley Scales of Infant Development (BSID) Description: Assesses mental functions (163 items assessing object permanence, memory, manipulation, problem solving, etc.) and both fine and gross motor function (81 items assessing hand function, posture, and locomotion). Appropriate from birth to 30 months. Requires 45 to 60 minutes to administer. Reference: Bayley N: Manual for the Bayley Scales of Infant Development. New York, Psychological Corporation, 1969. Name: Gesell Revised Developmental Schedules Description: Assess adaptive motor (145 items), gross motor (98 items), fine motor (56 items), and language and personalsocial development (81 items). For ages birth to 36 months. Requires about 45 minutes to administer. Reference: Knobloch H, Stevens F, Malone AF: Manual of Developmental Diagnosis (revised edition). New York, Harper & Row, 1980.
S58
III. MOTOR ASSESSMENTS Name: Test of Infant Motor Performance (TIMP) Description: Assess postural and selective control needed for functional movements in early infancy. Can be used for premature infants (as young as 32 weeks postconceptional age), and up to age 4 months. Requires 25 to 45 minutes to administer. References: Campbell SK, Osten ET, Kolobe THA, Fisher AG: Development of the Test of Infant Motor Performance, in Granger CV Gresham GE (eds): New Developments in Functional Assessment. Philadelphia, WB Saunders, 1993, pp 541-550. Developmental Motor Scales and Activity Cards. Allen, TX: DLM Teaching Resources, 1983. Name: Peabody Developmental Motor Scales (PDMS) Description: Gross motor scale assesses reflexes, balance, nonlocomotion and locomotor activities, and receipt and propulsion of objects. Fine motor scale assesses grasp, hand functions, eye-hand coordination, and manual dexterity. For ages birth to 42 months. Requires 45 to 60 minutes to administer. Reference: Folio M, Fewell R. Peabody Hinderer KA, Richardson PK, Atwater WS: Clinical implications of the Peabody Developmental Motor Scales: a constructive review. Phys Occup Ther Pediatr 1989; 9(2):81-106.
Measures in spasticity management
Muscle & Nerve Supplement 6 1997
Syllabus A pages 1-120
4/14/98 20:52
Page 59
Name: Toddler and Infant Motor Evaluation (TIME) Description: Qualitative motor assessment, including a parent interview to assess functional performance in dressing and other ADLs. For children ages birth to 42 months. Reference: Miller LJ: The Toddler and Infant Motor Evaluation. Tucson, AZ, Communication Skill Builders, 1994. Name: Bruininks-Oseretsky Test of Motor Proficiency Description: Tests gross and fine motor function; items stress coordination and balance. For children ages 4.5 to 14.5 years. Requires 45 to 60 minutes to administer; a short form is available. References: Bruininks RH: Bruininks-Oseretsky Test of Motor Proficiency: Examiner’s Manual. Circle Pines, MN, Americal Guidance Service, 1978.
IV. ASSESSMENTS DESIGNED FOR CHILDREN WITH DISABILITIES Name: Gross Motor Funtion Measure (GMFM) Description: Measures change over time in gross motor funtion in children with CP. Composed of 88 items in five dimensions: laying and rolling; sitting; crawling and kneeling; standing; and walking, running, and jumping. For children ages 5 months to 16 years. Requires 45 to 60 minutes to administer. References: Rosenbaum P, Cadman D, Kirpalani H. Pediatrics: Assessing quality of life, in Spilker B (ed): Quality of Life Assessment in Clinical Trials. New York, Raven Press, 1990, pp 205-215. Russell D, Rosenbaum P, Cadman D, Gowland C, Hardy S, Jarvis S: The Gross Motor Function Measure: a means to evaluate the effects of physical therapy. Dev Med Child Neurol 1989; 31:341-352. Name: Pediatric Evaluation of Disability Inventory (PEDI) Description: Detects functional limitations and disability in age-appropriate independence. It is also a tool for program evaluation in tracking progress in individual children. 197 items measure functional skill in self-care, mobility, and social function. 20 items assess extent of caregiver assistance and modifications needed. Requires 20 to 30 minutes to administer. References: Feldman AB, Haley SM, Coryell J: Concurrent and construct validity of the Pediatric Evaluation of Disability Inventory. Phys Ther 1990; 70:602-610. Hayley SM, Coster WJ, Faas RM: A content validity study of the Pediatric Evaluation of Disability Inventory. Pediatr Phys Ther 1991;3:177-184.
Measures in spasticity management Muscle & Nerve Supplement 6 1997
S59
Syllabus A pages 1-120
4/14/98 20:52
Page 60
Hayley SM, Coster WJ, Ludlow LH, Haltiwanger JT, Andrellos PJ: The Pediatric Evaluation of Disability Inventory: Development Standardization and Administration Manual. Boston, New England Medical Center Publications, 1992. Name: Functional Independence Measure for Children (Wee FIM) Description: Assesses caregiver assistance needed to accomplish daily tasks. For children ages 6 months to 12 years. Requires 20 to 30 minutes to administer. References: Granger CV, Hamilton BB, Kayton R. Guide for the Use of the Functional Independence Measure (WeeFIM) of the Uniform Data Set for Medical Rehabilitation. Buffalo, NY, Research Foundation, State University of New York, 1989. Msall ME, Roseberg S, DiGuadio KM, Braun SL, Duffy L, Granger CV: Pilot test for the Wee FIM for children with motor impairments (Abstract). Dev Med Child Neurol 1990; 32 (9 suppl 62):41.
S60
Measures in spasticity management Muscle & Nerve Supplement 6 1997