CRITICALLY APPRAISED PAPER (CAP)

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1 CRITICALLY APPRAISED PAPER (CAP) Smania, N., Gandolfi, M., Paolucci, S., Iosa, M., Ianes, P., Recchia, S., & Farina, S. (2012). Reduced-intensity modified constraint-induced movement therapy versus conventional therapy for upper extremity rehabilitation after stroke: A multicenter trial. Neurorehabilitation and Neural Repair, 26(9), CLINICAL BOTTOM LINE Traditional constraint-induced movement therapy (CIMT) requires restraint of the less-affected upper extremity during performance of intense, functionally oriented task practice with the paretic arm. The restraint of the less-affected upper extremity is meant to facilitate use of the paretic arm to reduce the likelihood of learned nonuse and increase the function of the affected arm. However, traditional CIMT protocols require extensive one-to-one therapy, which many health care systems cannot afford to provide. In response, the researchers of this study explored the efficacy of a modified CIMT (mcimt) program that would be less demanding than its traditional counterpart and would be more effective than a conventional rehabilitation program for patients with stroke. The modifications of a traditional CIMT protocol may include reduced restraint time, reduced training period (reduced duration of each session or reduced session frequency), or both. In the present study, the mcimt protocol included 2 hours of treatment per day, in comparison with 6 hours/day in traditional CIMT protocol, for 5 days/week for 2 consecutive weeks. The participants were also required to wear a mitt on their less-affected upper extremity for at least 12 of their waking hours, Monday through Friday. Previous mcimt studies have shown benefits of an mcimt protocol on amount of use, quality of movement, and function of the paretic arm; however, they included small sample sizes or did not perform a long-term follow-up assessment. In this study, participants who received the mcimt protocol were two times more likely to experience an improvement that could benefit their life in terms of motor and functional abilities than participants who received conventional therapy, evidenced by Wolf Motor Function Test Quality of Movement (WMFT-FA) and Motor Activity Log Quality of Movement (MAL-QOM) scores for the experimental group. The selfperceived improvement evidenced by MAL scores could lead to increased quality of life, selfconfidence, and self-efficacy and encourage stroke survivors to maintain active participation in their activities of daily living (ADLs), as well as their meaningful occupations, while incorporating and rehabilitating their affected arm. 1

2 Although the researchers hoped to explore the long-term effects of mcimt, results could not be concluded from this study because of a high dropout rate at the 3-month follow-up period. Further research needs to include a long-term follow-up (6 months 1 year) to further support the efficacy of mcimt. Despite these limitations, the present study does suggest that a lessdemanding mcimt protocol could improve function and use of the affected arm more than a conventional rehabilitation program for individuals with chronic stroke. RESEARCH OBJECTIVE(S) Primary objective: compare the effects of an mcimt protocol with the effects of a conventional rehabilitation program for arm paresis among patients with stroke Secondary objectives: demonstrate the long-term effects of the mcimt protocol, as well as its effect on quality of life DESIGN TYPE AND LEVEL OF EVIDENCE Level I: Multisite randomized controlled trial PARTICIPANT SELECTION The study was promoted by the Italian Society of Neurological Rehabilitation, involving nine clinical sites. The participants needed to meet all inclusion criteria. They were informed of the experimental nature of the study and gave their consent for participation. INCLUSION CRITERIA Participants needed to have had their first-ever ischemic or hemorrhagic stroke 3 24 months ago have 10 active wrist extension, at least 10 thumb abduction extension, and at least 10 extension at the level of the metacarpophalangeal and interphalangeal joints in at least two digits among the II III IV V fingers (these movements had to be repeated three times in 1 min, starting from the resting position) demonstrate adequate balance while independently standing from a sitting position and the ability to stand for at least 2 min without arm support Passive range of motion criteria included at least 90 shoulder flexion and abduction 45 shoulder external rotation 30 elbow extension 45 forearm supination and pronation (from neutral position) 30 wrist extension and finger extension to neutral, such that no metacarpophalangeal joint had a contracture EXCLUSION CRITERIA Individuals less than 18 or more than 85 years of age 2

3 Individuals who experienced a subarachnoid hemorrhage Individuals who scored 23/30 on the Mini-Mental State Examination, 2.5 on the MAL Amount of Use, 4 on the Visual Analog Scale for Pain score at the affected arm, and 11 or 26 on the Motricity Index pinch grip subscore Individuals participating in other pharmacological or rehabilitation studies during the study period Individuals who received treatment for upper limb spasticity (e.g., botulinum toxin) in the 3 months before the start of the study or during its execution PARTICIPANT CHARACTERISTICS N= (Number of participants taking part in the study) 59 #/ (%) Male: 49/(83%) #/ (%) Female: 10/(17%) Ethnicity: NR Disease/disability diagnosis: Ischemic or hemorrhagic stroke INTERVENTION(S) AND CONTROL GROUPS Group 1: Experimental group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Participants received 10 min of passive mobilization of affected arm joints through full range of motion to prevent secondary myoarticular damage and to give sensory stimulation. Participants engaged in 40 min of training based on repetitive practice and shaping and 10 min of standard ADLs that were challenging and contextually appropriate. 30 Clinical hospital; household activities were performed at home Therapist in the hospital, caregiver at home 5 days/week for 2 consecutive weeks: 1-hour individual treatment sessions as outpatients, and 1 hour of household activities Participants wore a splint on their unaffected arm for at least 12 of their waking hours (Monday Friday). 2 consecutive weeks Group 2: Control group Brief description of the intervention Participants received 20 min of passive mobilization and stretching of the affected arm, 30 min of exercises based on active mobility 3

4 tasks, and 10 min of standard ADLs, as in the experimental group. How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? 29 Clinical hospital; household activities were performed at home Therapist 5 days/week for 2 consecutive weeks: 1-hour individual treatment sessions as outpatients, and 1 hour of household activities 2 consecutive weeks Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: YES NO Explanation: No contamination biases present Co-intervention: YES NO Timing: Site: Explanation: No cointervention biases present Explanation: Duration of the study was 2 weeks because the reducedintensity mcimt protocol included reduced restraint time, a shortened training period, or both. Follow-up was done 3 months postintervention; however, because of a high dropout rate, examination of long-term effects of the mcimt protocol was limited. Explanation: Nine clinical hospital sites and participants home settings were used as intervention sites. Each clinical hospital site used different therapists for providing treatment protocols. Each participant s caregiver was responsible for home session supervision and recording of data. Use of different therapists to provide intervention: Explanation: Two therapists from each clinical hospital were trained for either the mcimt treatment protocol or the control group protocol to ensure uniformity. Caregivers were responsible for supervising and recording data for home sessions. 4

5 MEASURES AND OUTCOMES Complete for each measure relevant for occupational therapy: Measure 1: Primary Outcome: WMFT Name/type of WMFT measure used: What outcome is measured? Quality of movement (WMFT-FA) is scored on a 6-point functional ability scale (0 = does not attempt, 5 = normal movement). The minimal clinically important difference (MCID) values are 1.0 point for the affected dominant arm and 1.2 points for the affected nondominant side. reliable (as reported in the article)? valid (as reported in the article)? When is the measure used? Test performance (WMFT-T) measures the time to complete each task (2 min maximum). The MCID is 19.0 seconds. YES NR YES NR Before and after intervention and at 3-month follow-up Measure 2: Primary Outcome: MAL Name/type of measure used: What outcome is measured? reliable as reported in the article? valid as reported in the article? When is the measure used? MAL: amount of use (MAL-AOU), quality of movement (MAL-QOM) Assesses how the affected arm is used spontaneously to accomplish 30 daily activities outside of the clinical setting. MCID for MAL-AOU and MAL-QOM is 1.0 point for the affected dominant arm and 1.1 points for the affected nondominant side. YES NR YES NR Before and after intervention and at 3-month follow-up Measure 3: Secondary Outcome: Ashworth Scale (AS) Name/type of AS measure used: What outcome is Grades the resistance of a relaxed limb to rapid passive stretch in five measured? stages. The paretic arm elbow spasticity was evaluated in this study. 5

6 reliable as reported in the article? valid as reported in the article? When is the measure used? YES NR Before and after treatment and at 3-month follow-up Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. Explanation: Participants were specifically asked not to wear the mitt to evaluation sessions and not to discuss their treatment, to maintain blinding of the evaluators. Recall or memory bias. Check yes, no, or NR, and if yes, explain. Others (List and explain): N/A Explanation: The MAL is a patient-rated, semistructured interview and therefore can have recall or memory bias. A detailed patient diary is needed to monitor intensity of household training. RESULTS List key findings based on study objectives Include statistical significance where appropriate (p<0.05) Include effect size if reported The MCID refers to the smallest change in a score of an outcome that the participant would perceive as beneficial and meaningful. Primary outcomes: Statistically significant differences were found for the WMFT-FA (Time Group, p =.010), MAL-AOU (p <.001), and MAL- QOM (p <.001). These differences were significant both after treatment (p <.01) and at 3-month follow-up (p <.01). Results of the Time Group interaction were not significant in the WMFT-T, probably because of the high standard deviation observed in this parameter. Both groups showed an overall significant improvement in performance on all outcome measures. After complete-case analyses were performed: After the intervention phase, the difference found in the experimental group for WMFT- FA tended to the MCID (.81 instead of 1.0), whereas at follow-up it was ahead of the 6

7 estimated score ( 1.39). The control group did not reach the MCID for the WMFT-FA after the intervention phase or after the follow-up phase. Neither group reached the MCID for the WMFT-T after the intervention or the followup phase. For the MAL-QOM, the experimental group achieved the MCID after both the intervention and the follow-up phase, whereas the control gorup did not reach the MCID. Secondary outcomes: Between-groups comparison showed statistically significant differences on the AS (Time Group, p =.016). This difference was significant only at the 3-month follow-up (p =.021). This significant difference was not found when complete-case analysis was used. The AS revealed decrease in spasticity in both groups. Was this study adequately powered (large enough to show a difference)? (Check yes or no, and include a brief explanation) YES NO Explanation: The researchers originally hypothesized that they needed 62 participants to show a significant difference in all outcome measures. However, because of the high dropout rate at 3-month follow-up, the strength of these results are limited. Were the analysis methods appropriate? (Check yes or no, and include a brief explanation) Explanation: An intention-to-treat analysis was used because of the high dropout rate. However, the researchers also conducted a complete case analysis, using only patients with complete data, to verify the validity of the results. The researchers used parametric tests for inferential statistics because of a normal distribution of data. Were statistics appropriately reported (in written or table format)? (Check yes or no, and include a brief explanation) Explanation: The statistics were appropriately reported in both table and written format. Was the percent/number of subjects/participants who dropped out of the study reported? Limitations: What are the overall study limitations? There were high dropout rates at the 3-month follow-up assessment; therefore, long-term 7

8 effects of mcimt could not be concluded. Although participants were highly motivated to receive treatment during the intervention phase, they lacked motivation to travel to the rehabilitation centers solely for the purpose of the 3-month clinical evaluation follow-up. CONCLUSIONS State the authors conclusions related to the research objectives. This study suggests that an mcimt training program could improve function and use of the affected arm and be more effective than a conventional rehabilitation program for outpatients with chronic stroke. Although there was no significant improvement in the time to execute a task (WMFT), participants treated with mcimt were two times more likely than the conventional therapy group to experience an improvement that could provide a perceivable benefit in their life in terms of motor and functional abilities. The mcimt group was found to have an increase in quality of movement and functional ability through the WMFT-FA and MAL-QOM, respectively, and a decrease in spasticity through the AS. Because the experimental and control groups received different treatments, this study could not compare the effectiveness of treatment intensity nor the effectiveness of restraining procedures. The long-term effects of mcimt also could not be concluded from this study because of a high dropout rate at the 3-month follow-up period. Further research needs to be done to look at the long-term effects of an mcimt protocol, as well as to compare the effects of mcimt and the traditional CIMT protocol. This work is based on the evidence-based literature review completed by Aileen Imai, OTS, Myka Winder, OTD, OTR/L, faculty advisor, University of Southern California. 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. For personal or educational use only. All other uses require permission from AOTA. Contact: 8