CRITICALLY APPRAISED PAPER (CAP) Dahl, A., Askim, T., Stock, R., Langørgen, E., Lydersen, S., & Indredavik, B. (2008). Short- and long-term outcome of constraint-induced movement therapy after stroke: A randomized controlled feasibility trial. Clinical Rehabilitation, 22(5), 436 447. http://dx.doi.org/10.1177/0269215507084581 CLINICAL BOTTOM LINE: Constraint-induced movement therapy (CIMT) is an option for occupational therapy intervention that has gained increasing attention in recent years. CIMT involves constraining the unaffected extremity (e.g., with a mitten) for the majority of one s waking hours to encourage the use of the affected extremity after a stroke. Task-specific training is introduced during therapy to facilitate rehabilitation of the affected extremity. This research study compares the short- and long-term outcomes of CIMT with traditional rehabilitation among a group of clients poststroke. The authors defined traditional rehabilitation as community-based follow-up aimed at meeting the clients needs, addressing both the upper and the lower extremities. When needed, clients were provided with inpatient rehabilitation. Physiotherapy was provided twice per week as outpatient therapy and after inpatient rehabilitation for those receiving inpatient services. Clients received services at Trondheim University Hospital (for inpatient and outpatient services). Participants ranged from 2 weeks to 8 years poststroke. Outcome measures included the Wolf Motor Function Test (WMFT), the Motor Activity Log (MAL), the Functional Independence Measure (FIM), and the Stroke Impact Scale (SIS). Participants were assessed at the beginning of the study for baseline measurements, directly after the study for postassessment, and again at a 6-month follow-up. At the postassessment, participants who received CIMT performed better than those who received traditional rehabilitation on the WMFT and the MAL. There were no statistically significant differences in performance on the FIM for either group. At the 6-month follow-up assessment, there were no statistically significant differences in performance between the CIMT group and the traditional rehabilitation group on any of the assessments, with the exception of one section of the SIS, where the CIMT group showed significant improvement (the SIS was only administered at baseline and at 6-month follow-up, not at postassessment).
The results of the study suggest that CIMT is more effective than traditional rehabilitation in improving motor function in the short term. However, the same claim cannot be made over the long term, given that both the CIMT and the traditional rehabilitation group showed no statistically significant differences in performance on the outcome measures (with the exception of the self-perceived strength section of the SIS, which favored the CIMT group). With this in mind, clinicians should use their own judgment when selecting intervention tools and strategies for clients and should seek to incorporate intervention options deemed acceptable as evidencebased practice when possible to provide the best care based on current knowledge. The results of this study suggest that CIMT and traditional rehabilitation are about equally effective over time. Therefore, therapists may choose to implement one strategy over another on the basis of a client s individual needs, preferences, response to therapy, and availability of resources, among other factors. However, the study does support the use of CIMT as a form of group therapy and supports its use in group settings where feasible and desired. This is particularly admirable in settings where resources (e.g., therapists, materials) are limited. The strengths of the study include that the study design was a randomized controlled feasibility trial (Level I evidence) with evaluations that were blinded and with follow-up assessments completed for all outcome measures. Also, the outcome measures chosen to assess recovery are well known and highly recognized as being reputable for this population. Additionally, all participants completed the study, with no dropouts, which further strengthens the results. In contrast, there are also several limitations. First, the sample size was rather small, with only 30 participants. In addition, there was much variability in the amount of time that had elapsed for the participants since their stroke (2 weeks to 8 years), which makes it difficult to generalize results, because the amount of time for recovery since stroke could have affected participants progress in the study. Finally, no details are available regarding the traditional rehabilitation provided to clients, so it is unclear to what degree (e.g., intensity, length of time) participants in this group were actually treated and how. RESEARCH OBJECTIVE(S) List study objectives. Assess and compare the effect of CIMT versus traditional rehabilitation over the short term and long term, with emphasis on arm motor function, independence in activities of daily living (ADLs), and self-perception of health among patients after stroke Assess the feasibility of CIMT as a form of group therapy in Norway for participants in an inpatient setting DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled feasibility trial SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. Participants were recruited from the stroke unit at Trondheim University Hospital and through 2
announcements made at other hospitals and rehabilitation facilities in neighboring counties. Patients with unilateral hand impairment who were 2 weeks to 8 years poststroke were recruited. Inclusion Criteria Diagnosis of a stroke (as defined by World Health Organization) Weakness, reduced dexterity, or both in affected hand (unilateral hand impairment) At least 2 weeks since onset of stroke Score of 0 2 points on modified Rankin Scale (before the stroke) Greater than 20 active wrist extension and 10 active finger extension Score of 20 points or more on the Mini-Mental State Examination scale Ages 18 80 years Willingness and ability to sign informed consent Favorable medical exam Exclusion Criteria Presence of neurological diseases other than stroke Unstable cardiovascular disease Severe depression (greater than 12 points on the Montgomery and Aasberg Depression Rating Scale Marked neglect (line bisection more than 2 cm over the midline) Less than 6 months life expectancy Previous stroke Insufficient endurance to participate in the study (as determined by clinical evaluators) SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 30 #/ (%) Male 23/(77%) #/ (%) Female 7/(23%) Ethnicity Disease/disability diagnosis INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1: CIMT group Brief description of the intervention Ethnicity statistics were not reported. The study was conducted within the Norwegian health care system, however, and we may hypothesize that most, if not all, participants were Norwegian. Unilateral hand impairment After the first onset of stroke, all participants received basic rehabilitation and physiotherapy during their initial hospital stay. No data are available regarding length of hospital stays for participants, nor are any correlations between length of initial stay and performance in the study calculated or provided. Before being randomized into the experimental or control groups, participants also 3
received further traditional rehabilitation, as directed by their family physician. However, no data are available regarding these recommendations for traditional rehabilitation by the participants family physicians. Participants who received CIMT trained for 6 hr/day for 10 consecutive weekdays. CIMT intervention was carried out in groups of 4. Groups were led by an occupational and physical therapist, with help from nurses who had received specialized training. The therapists provided CIMT by immobilizing the nonaffected upper extremity with a mitten for 90% of the participant s waking hours. The mitten was intended to restrict use of the nonaffected extremity to encourage use of the affected extremity. How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Each participant identified five daily activities related to ADLs or leisure occupations from ten different fields, which helped guide the focus of activities for intervention. Activities ranged from simple to complex and were adjusted or graded on the basis of the client s individual needs (e.g., weight, tempo, repetitions). Participants were given half-hour breaks when shifting to different activity fields or categories. 18 Inpatient rehabilitation clinic at Trondheim University Hospital in Norway A physical therapist and an occupational therapist worked together to provide intervention to these participants in a group format, with assistance from nurses trained in CIMT. 10 consecutive weekdays 2 weeks; mean training time = 5.7 hr/day, mean time with mitten use = 13.1 hr per day Group 2: Traditional rehabilitation Brief description of the intervention After the first onset of stroke, all participants received basic rehabilitation and physiotherapy during their initial hospital stay. Before being randomized into the experimental or control group, participants also received further traditional rehabilitation, as directed by their family physician, although no data are available regarding such recommendations by the participants family physician. According to the authors, traditional rehabilitation included community-based follow-up treatment that addressed the client s needs, incorporating training for the upper and lower extremity, as necessary. No further information is available 4
regarding specific aspects of traditional rehabilitation received by these participants. How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Inpatient rehabilitation was administered to participants who needed more long-term care; otherwise (or after their time in inpatient rehabilitation), the participants were followed up with physiotherapy and occupational therapy (in conjunction with the primary health care system) twice per week. It must also be noted that after the conclusion of the study, the control group (traditional rehabilitation group) was offered CIMT, if desired. 12 Outpatient rehabilitation clinic at Trondheim University Hospital in Norway Occupational therapist and physiotherapist at Trondheim University Hospital Twice per week Mean duration of interventions were as follows: time in physiotherapy = 1.7 hr/week, time in occupational therapy = 0.8 hr/week. Number of weeks of treatment was not specified. Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: YES Comment: The traditional rehabilitation group was offered CIMT, but only NO after the 6-month follow-up results were collected. Therefore, the results NR should not have been affected by contamination. Co-intervention: YES NR Timing: YES NR Comment: The results of the study would be better supported had the researchers explored or reported cointerventions. Comment: Although the article does not address it, timing bias could be a factor, because the treatment group (CIMT) was treated for 6 hr/day for 10 consecutive weekdays, whereas the control group (traditional rehabilitation) was only treated twice per week for a little over an hour for each treatment session (for an unspecified number of weeks). Site: 5
YES NR Comment: The CIMT group was treated at an inpatient rehabilitation facility, whereas the traditional rehabilitation group was treated in a communitybased setting where the option for inpatient rehabilitation was only provided when necessary. Use of different therapists to provide intervention: YES Comment: Different therapists provided the CIMT group therapy and the traditional rehabilitation therapy. A physical and occupational therapist NR provided CIMT, whereas a physiotherapist and occupational therapist provided traditional rehabilitation. No data are available regarding whether the same occupational therapist was used for both groups. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Name/type of measure used: Wolf Motor Function Test (WMFT) This was the primary outcome measure for this study. The test consists of two strength tests and 15 timed tasks. Movements are graded on a 6-point scale. What outcome was measured? reliable? valid? When is the measure used? The mean of the 15 timed tasks was used as a test parameter and measure of upper extremity motor function. At the beginning of the study for pretesting (to establish baseline scores), at posttesting at the conclusion of the treatment sessions, and at the 6-month follow-up assessment Measure 2: Name/type of measure used: What outcome was measured? reliable? Motor Activity Log (MAL; 30 items) Structured interview used to evaluate the use of the affected extremity in ADLs. Clients report on the quality of their movement as well as the amount of time the affected extremity is used. Served as a way to measure function of the affected extremity, as reported by the client 6
valid? When is the measure used? At the beginning of the study for pretesting (to establish baseline scores), at posttesting at the conclusion of the treatment sessions, and at the 6-month follow-up assessment Measure 3: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? Functional Independence Measure (FIM) Level of independence in ADLs. A total of 13 motor items and 5 cognitive and social items are included. Items are rated from 1 (total assistance) to 7 (total independence) on the basis of need for assistance. At the beginning of the study for pretesting (to establish baseline scores), at posttesting at the conclusion of the treatment sessions, and at the 6-month follow-up assessment Measure 4: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? Stroke Impact Scale (SIS) Self-report tool used to measure the individual s own perception of his or her health and participation or engagement in occupations. Participants perception of health in eight different domains (a total of 64 items) on a scale from 1 to 5, as well as their perception of total recovery since time of stroke (scale of 0 to 100) At the beginning of the study for pretesting (to establish baseline scores) and at 6-month follow-up Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. YES Comment: NR Recall or memory bias. Check yes, no, or NR, and if yes, explain. 7
YES NR Comment: Although it is not reported, there is a potential for memory bias among participants in their responses to the SIS, because they might not have correctly recalled their experiences in recovery in some of the domains. Others (list and explain): N/A RESULTS List key findings based on study objectives Include statistical significance where appropriate (p<0.05) Include effect size if reported From baseline to postassessment, the experimental (CIMT) group performed better on both parts of the WMFT (p <.001). However, from baseline to 6-month follow-up, there were no significant differences between the performance of the experimental and control groups on the WMFT. A similar trend was also true for the MAL. The postassessment results favored the CIMT group; however, the results were not significant (amount of use score, p =.097; quality of movement score, p =.105). From baseline to the 6-month follow-up, there were no statistically significant differences between the two groups on the MAL. On the FIM, there was no significant difference between the experimental and control groups at postassessment (p =.516). By the 6- month follow-up, both groups had raised their scores from baseline; however, the difference between the groups was not significant. For the SIS, data were only collected at baseline and at 6-month follow-up. On the section of the SIS related to self-perceived strength, the CIMT group showed statistically significant improvement (p =.003). For the categories of memory, communication, emotion, and overall recovery, both the CIMT and the traditional rehabilitation group significantly raised their scores; however, there were no differences between the two groups on any of these areas. The results of the study demonstrate significant improvement among participants directly after CIMT intervention, although the effects did not seem to last over time. Although this study validates that CIMT is effective in the short term (and even preferable to traditional rehabilitation, on the basis of the WMFT, the MAL, and one section of the SIS), the study was not able to determine whether CIMT was superior to traditional rehabilitation over the long term. The lack of statistically significant differences in scoring between the two groups at the 6-month follow-up assessment suggests that, in the long run, both approaches to rehabilitation (CIMT and traditional rehabilitation) may be equally effective. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. YES Comment: The sample size for this study was too small to generalize the NO results (30 total participants; 18 participants in the CIMT group, and 12 NR participants in the traditional rehabilitation group). 8
Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. YES Comment: Paired t tests were used to analyze changes within the groups, and analysis of covariance was used to analyze differences between the groups. NR Two-sided p values less than.05 were considered to be statistically significant. A second-level analysis adjusted for age, gender, time from onset of stroke, and which dominant side was affected by stroke. Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. YES Comment: Statistics were reported in narrative format and in various tables to summarize the data recorded during the study. Tables reported on data from all four assessments (WMFT, MAL, FIM, and SIS), as well as baseline characteristics of participants. Mean, standard deviation, within-group differences (reported with confidence intervals), and between-groups differences (reported with analysis of covariance p values) were included, as appropriate for the assessments. Effect size was not reported in the study. Was the percent/number of subjects/participants who dropped out of the study reported? YES Limitations: What are the overall study limitations? Comment: No participants (0%) dropped out of the study. Small sample size (30 total participants; 18 participants in the CIMT group, and 12 participants in the traditional rehabilitation group) makes it difficult to generalize results; lack of statistical power Bias toward the CIMT group, because the number of participants was larger for the CIMT group (18) than the traditional rehabilitation group (12). Amount of time spent in traditional rehabilitation group is reported for each week; however, no data are available on the number of weeks of therapy for the traditional rehabilitation group. This makes it difficult to compare the element of time for CIMT with traditional rehabilitation, because we do not know the difference in total therapy time received between these two groups. High variability in time since stroke for the participants: Some participants had experienced their stroke as recently as 2 weeks ago, whereas for others it had been as long as 8 years. This large gap in time created opportunity for variability in skills and recovery of the participants, which could ultimately affect performance. Ideally, the participants should be more homogenous in this regard. No data are available on the description of the traditional rehabilitation program. Therefore, it is unknown what intervention might have looked like for those individuals. Similarly, there are no data on the effort from the CIMT group postintervention. These two factors reduce the overall integrity of the study. 9
CONCLUSIONS State the authors conclusions related to the research objectives. This study produced several conclusions related to the research objectives. First, in the short term, CIMT did seem to be superior to traditional rehabilitation to improve arm motor function in clients poststroke. However, CIMT did not seem to be superior to traditional rehabilitation in clients after stroke in the long term. With this in mind, CIMT or traditional rehabilitation may be equally acceptable for clients poststroke in the long term. Second, the potential for CIMT to improve independence and daily performance in functional activities is uncertain at this time. As a result, both CIMT and traditional rehabilitation may be equally acceptable options for improving independence and daily function. Finally, CIMT in a group therapy setting did seem to be feasible for clients poststroke. The authors stated that future research should investigate whether an equivalent amount of traditional rehabilitation produces the same results as CIMT. Similarly, they suggested further evaluating which components of CIMT are the most significant in therapy (i.e., intensity of training, constraining the nonaffected extremity to encourage or force use of the affected extremity, the impact of the repetitive tasks of the treatment, as well as how these factors work in combination to affect clients). This work is based on the evidence-based literature review completed by Wesley J. Bill and Camille Skubik-Peplaski, Ph.D., OTR/L, FAOTA, BCP, faculty advisor, Eastern Kentucky University CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998, by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, and M. Westmorland, McMaster University. Used with permission. 10