CRITICALLY APPRAISED PAPER (CAP) FOCUSED QUESTION What is the effectiveness of a modified constraint-induced therapy (mcit) intervention compared to conventional rehabilitation methods for the rehabilitation of the affected upper extremity (UE) in individuals who are more than 12 months poststroke? Page, S. J., Levine, P., Leonard, A., Szaflarski, J. P., & Kissela, B. M. (2008). Modified constraint-induced therapy in chronic stroke: Results of a single-blinded randomizedcontrol trial. Physical Therapy, 88(3), 333 340. http://dx.doi.org/10.2522/ptj.20060029 CLINICAL BOTTOM LINE: The results of this study indicate that mcit principles that incorporate restriction of the lessaffected UE during functional activity can increase the use of the more-affected limb in firsttime stroke clients who are more than 12 months post-event. The first component of this intervention incorporates clinic-based functional movement rehabilitation in which the therapist and client collaborate to devise functional goals. The second component is a home-based restraint diet of the less-affected UE carried out by the client. The involvement of the client in the decision-making process during both components of this intervention is indicative of clientcentered practice. However, limitations to this study include (1) the absence of measures to define adequate timing and duration of therapy sessions required to achieve optimal motor changes using mcit techniques; (2) the potential for process bias among participants in the mcit due to the use of behavior contracts, an intervention component not included in many of the previous mcit studies in which similar results were reported; and (3) the absence of comparison to a commonly used standard of care for this condition that employs task-specific training without shaping. Future research addressing timing and duration of therapy sessions should be conducted to ensure the efficacy of mcit techniques by occupational therapists to facilitate increased use of the more-affected UE for this population. Conducting this research will enhance the repertoire of evidence-based interventions at the disposal of occupational therapists and, furthermore, assure them that they are using valid and reliable treatment technique. 1
RESEARCH OBJECTIVE(S) List study objectives. To compare the efficacy of a reimbursable, outpatient-mcit protocol in clients who are more than 12 months after stroke with that of a time-matched rehabilitation (TR) program for the more-affected arm or a nontreatment control. DESIGN TYPE AND LEVEL OF EVIDENCE: Randomized controlled trial (RCT) Level I Single-blinded Limitations (appropriateness of study design): Was the study design type appropriate for the knowledge level about this topic? Circle yes or no, and if no, explain. SAMPLE SELECTION How were subjects selected to participate? Please describe. Subjects in this study voluntarily responded to advertisements placed in physical therapy and neurology clinics in the Midwestern United States. Inclusion Criteria Between 18 and 80 years of age; only a single occurrence of stroke and more than 12 months post-event; demonstrated ability to electively and actively extend the more-affected hand no less than 10 at the metacarpophalangeal and interphalangeal joints and 20 at the wrist; a score of 69 or greater on the Modified Mini Mental Status Examination; and demonstrated nonuse of the more-affected arm, as indicted by a score of less than 2.5 on the Motor Activity Log (MAL) scale Exclusion Criteria Excessive spasticity (quantified by a score of 3 on the Modified Ashworth Spasticity Scale); excessive pain in the more-affected arm (measured by a score of 4 or greater on a 10-point visual analog scale); individuals still enrolled in any form of physical rehabilitation; and individuals who were participating in any experimental rehabilitation or drug studies at the time. SAMPLE CHARACTERISTICS N = 35 % Dropouts 0 #/(%) Male 22 (62.86%) #/(%) Female 13 (37.14%) 2
Ethnicity NR Disease/disability diagnosis Left or right hemiparesis secondary to stroke. Check appropriate : < 20/study 20 50/study 51 100/study 101 149/study 150 200/study INTERVENTION(S) AND CONTROL GROUPS Add s if necessary Group 1: mcit Group Brief Description The mcit involved two 10-week components delivered simultaneously to each participant. The first component took place 3 days a week in a physical therapy clinic and included the use of operant conditioning to shape the participant s perception of motor skills in his or her more-affected arm. The shaping technique used was positive verbal encouragement, which was implemented during participation in two or three client-/therapist-chosen activities involving the more-affected arm, such as writing or eating utensil use. The second component took place at the participants homes and involved the initiation and signing of a behavioral contract between the participant and the principal investigator of the study, thereby guaranteeing adherence to the training regimen. The home training regimen consisted of 5 hours of hemi-sling arm restraint and restrictive hand mitt wear of the less-affected limb each weekday for the duration of the 10- week period. Timing of sling and hand mitt restraint wear was to be during a specific period of the day identified by the participant as being the time of most use. Component 1 = (1) Component 2 = (2) Setting Who Delivered? Frequency? Duration? (1) Physical therapy clinic (2) Participants home (1) Physical therapist (2) Caregiver (1) 3 days/week/½ hr sessions (2) Every weekday (1) 10 weeks (2) 10 weeks Group 2: Time-Matched Rehabilitation Program (TR) for the More-Affected Arm Brief Description The TR program sessions focused on the use of the proprioceptive neuromuscular facilitation (PNF) technique. The PNF was implemented through functional task participation and stretching, including extension, adduction, and internal rotation of the shoulder with the elbow extended and with finger and wrist flexion involving the participant s more-affected limb. When necessary, sessions concluded with therapist facilitation in education on compensatory strategies by which the more-affected arm could be assisted by the less-affected arm during functional tasks. 3
Setting Who Delivered? Frequency? Duration? Physical therapy clinic Physical therapist 3 days per week (½ hr session each day) 10 weeks Group 3: Nontreatment Control Group Brief Description Setting Who Delivered? Frequency? Duration? N/A N/A N/A 10 weeks Intervention Biases: Circle yes or no and explain if needed. Contamination Co-intervention Timing Site Frequency and duration for the mcit and TR treatment s entailed outpatient clinical treatments 3 days per week for 10 weeks, with all sessions being one-half hour in length. One component of the mcit took place at the participants homes, which may result in a higher satisfaction of the intervention. Use of different therapists to provide intervention All pretest/posttest measurements were administered by persons identified as research team members. Three therapists were hired and randomly assigned to administer either the mcit or TR protocol. To ensure accuracy in reporting a part in an extensive inservice -based training session that included among the three therapists, prior to random assignment, each therapist took critical analyses of relevant stroke, mcit, and CIT literature. Therapists also participated in a thorough cross-checking process to further support interrater reliability in protocol administration. 4
MEASURES AND OUTCOMES Complete for each relevant measure when answering the evidence-based question: Name of measure, what outcome was measured, whether the measure is reliable and valid (as reported in article yes/no/nr [not reported]), and how frequently the measure was used. Action Research Arm Test (ARAT), which measures grasp, grip, pinch, and gross movement and has a high intrarater (r =.99) and retest (r =.98) reliability and validity. This measure was administered on three occasions: twice pretest, 1 week apart, with the second pretest concluding 1 week prior to treatment, and once posttest, 1 week after completion of therapy. Name of measure, what outcome was measured, whether the measure is reliable and valid (as reported in article yes/no/nr [not reported]), and how frequently the measure was used. The 66-point upper-extremity section of the Fugl Meyer Assessment of Motor Recovery after Stroke (FM), which measures several impairment dimensions and has been shown to have a high test retest reliability (total =.98.99; subtests =.97 1.00), interrater reliability, and construct validity. Components of this measure were administered on three occasions: twice pretest, 1 week apart, with the second pretest concluding 1 week prior to treatment, and once posttest, 1 week after completion of therapy. Name of measure, what outcome was measured, whether the measure is reliable and valid (as reported in article yes/no/nr [not reported]), and how frequently the measure was used. The 6-point Amount of Use (AOU) scale and the 6-point Quality of Movement scale (QOM), both components of the MAL, a semi-structured interview measuring how people use their more affected limbs for ADL tasks. The MAL also has been shown to be a valid and reliable scale of arm use and movement quality in real world settings. Each component of the MAL was administered on three occasions: twice pretest, 1 week apart, with the second pretest concluding 1 week prior to treatment, and once posttest, 1 week after completion of therapy. Measurement Biases Were the evaluators blind to treatment status? Circle yes or no, and if no, explain. Recall or memory bias. Circle yes or no, and if yes, explain. Activities of daily living cited in the Motor Activity Log (MAL) are not directly observed by therapist and thus rely on client recall. Others (list and explain): A behavioral contract signed by the mcit may have biased the outcomes because participants may have felt morally compelled to fulfill their obligation to participate accordingly. 5
RESULTS List results of outcomes relevant to answering the focused question Include statistical significance where appropriate (p < 0.05) Include effect size if reported A significant treatment effect of +10.81 points was seen in the mcit intervention on the ARAT (F = 13.1; df = 2,31; p <.0001) as compared to +3.00 for the TR and +0.90 for the control. Similar significance in the treatment effect in favor of the mcit was seen in the MAL AOU scale (+2.1; F = 49.1; p <.01) and QOM scale (+1.1; f = 63.1; p <.01), with no significant changes noted in the TR and control s. Although there was found to be no significant treatment effect among the intervention s on the FM, mean improvements of +7.4 were exhibited by the mcit, with the TR showing a minor change of +4.6 and the control demonstrating a range of negative to small changes within their mean score of +2.8. Results of the Caregiver MAL indicated only minor changes within the mcit condition (AOU scale = +2.3, QOM scale= +1.5) as compared to reporting from caregivers in the TR (AOU scale = +.06, QOM = +0.2), and those in the control (AOU scale = -0.3, QOM scale=0.0). Was this study adequately powered (large enough to show a difference)? Circle yes or no, and if no, explain. Were appropriate analytic methods used? Circle yes or no, and if no, explain. Were statistics appropriately reported (in written or table format)? Circle yes or no, and if no, explain. CONCLUSIONS State the authors conclusions that are applicable to answering the evidence-based question. The data obtained in this study suggest that when compared to conventional TR methods that focus on proprioceptive and neuromuscular facilitation, the task-specific repetitive training treatment intervention of mcit promotes a significantly greater increase in affected arm use and function in single-event stroke patients who are more than 12 months post-event. Results of this study also revealed that the amount of change was comparable to that of the more rigorous constraint-induced therapy protocol, a treatment that has shown to be effective, but not reimbursable due its temporal and physical restraint durations. These findings parallel previous research conclusions regarding the efficacy of mcit, a reimbursable outpatient intervention. 6
This work is based on the evidence-based literature review completed by Jim Bales, OTS, and Kelly Erickson, PhD, OTR/L, Faculty Advisor, College of St. Scholastica. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998, by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, & M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: www.copyright.com 7