CRITICALLY APPRAISED PAPER (CAP)

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1 CRITICALLY APPRAISED PAPER (CAP) De Brito Brandao, M., Gordon, A. M., & Mancini, M. C. (2012). Functional impact of constraint therapy and bimanual training in children with cerebral palsy: A randomized controlled trial. American Journal of Occupational Therapy, 66, CLINICAL BOTTOM LINE Children with hemiplegia have difficulty performing tasks requiring the use of both hands, which makes it difficult to perform many self-care and functional activities (Van Zelst, Miller, Russo, Murchland, & Crotty, 2006). This Level I randomized controlled trial examined the effects of high-intensity constraint-induced movement therapy (CIMT) and bimanual task training on functional performance among children with cerebral palsy with unilateral hemiparesis. The results of the study show that 6 hours of daily task practice significantly improved scores on the Pediatric Evaluation of Disability Inventory (PEDI) and ratings of parents perceptions of performance and satisfaction on the Canadian Occupational Performance Measure (COPM). There was no significant difference between the groups, however. Parents perceptions of goal attainment improved for both groups, although more so in the bimanual therapy group; however, the two groups were not significantly different. In both treatment conditions, participants achieved goals they practiced as part of intensive training as well as those that they did not. The results of the study support intensive task practice, but they do not favor one intervention protocol over another. Furthermore, the results suggest that intensive task practice can generalize to upper extremity goals that individuals did not practice as part of the therapy session. The study was not powered, and the authors did not indicate whether the sample was large enough to detect differences between the groups. An additional limitation of the study is its lack of blinded raters. RESEARCH OBJECTIVE(S) 1

2 To determine Whether CIMT or hand arm bimanual intensive therapy (HABIT) led to improvement in daily functioning outcomes Whether changes in functional outcomes were different after CIMT versus HABIT Whether caregivers perceived that the children achieved functional goals as a result of CIMT or HABIT Whether there was a significant difference in the change noted by the participants of the CIMT group versus those of the HABIT group DESIGN TYPE AND LEVEL OF EVIDENCE Level I, randomized controlled trial, nonblinded PARTICIPANT SELECTION How were participants recruited and selected to participate? The participants were recruited from a larger randomized controlled study for children with hemiplegia. Inclusion criteria: Hemiplegia with a difference of at least 50% between the two limbs on timed motor tasks of the Jebsen Taylor Test of Hand Function (without the Writing subtest; Jebsen, Taylor, Trieschmann, Trotter, & Howard, 1969) The ability to extend the wrist at least 20 and fingers 10 from full flexion Typical cognitive abilities (i.e., mainstreamed in school) Exclusion criteria: Exclusion criteria were not described. PARTICIPANT CHARACTERISTICS N= 16 #/ % Male: 10/(62.5%) #/ % Female: 6/(37.5%) 2

3 Ethnicity: Not reported Disease/disability diagnosis: 9 (56%) left-side hemiplegia, 7 (44%) right-side hemiplegia INTERVENTION AND CONTROL GROUPS Group 1: CIMT 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 unaffected arm was restrained with a sling. Participants engaged in activities with their affected arm. Activities included fine-motor activities, board games, card games, self-care activities, and gross-motor activities. The researchers graded activities for each participant to promote success. Each participant had a one-on-one interventionist, although some activities were performed in a group. 8: 6 boys, 2 girls In a room on the Teachers College, Columbia University, campus in New York Occupational therapists; physical therapists; and graduate students in kinesiology, neuroscience, speech pathology, or psychology delivered the intervention. All were trained in the protocol, and graduate students were supervised by occupational therapists and physical therapists. 6 hours a day with interventionist and 1 hour a day of unilateral home practice with parents, for a total 90 hours of task practice (however, no restraint was used for home practice) 15 days Group 2: HABIT group 3

4 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 engaged in activities using both hands. Activities were structured to improve the underlying impairments in the affected hand and to encourage the use of both hands, with the affected arm increasingly performing parts of activities. Activities included finemotor activities, board games, card games, self-care activities, and gross-motor activities. Each participant had a one-on-one interventionist, although some activities were performed in a group. Grading procedures were used to increase the complexity, speed, and accuracy demands of chosen tasks. 8: 4 boys and 4 girls In a room on the Teachers College, Columbia University, campus in New York Occupational therapists; physical therapists; and graduate students in kinesiology, neuroscience, speech pathology, or psychology delivered the intervention. All were trained in the protocol, and graduate students were supervised by occupational therapists and physical therapists. 6 hours a day plus 1 hour a day at home with parents 15 days INTERVENTION BIASES Contamination: Participants in the CIMT group did not practice any bimanual skills. CIMT and HABIT training took place in separate rooms with different interventionists. Co-intervention: There was no report of participants receiving another intervention at the time of the study. Additionally, participants took part in this intervention for 6 hours a day; therefore, they likely did not have an opportunity to receive another intervention during the time of the study. Timing of intervention: 4

5 The intervention was conducted over a short period (15 days), which reduces the risk that changes occurred as a result of maturation. The intervention was intense, however, so researchers might have noted change. Site of intervention: Intervention for the two groups took place in separate rooms on the same university campus. Use of different therapists to provide intervention: Both groups had similar providers who were trained in the protocols and supervised by an occupational therapist or physical therapist. Baseline equality: No significant differences in functional performance measures was reported. MEASURES AND OUTCOMES (Report only on measures relevant to occupational therapy practice) Measure 1: PEDI Name/type of measure used: What outcome is measured? Is the measure reliable (as reported in the article)? Is the measure valid (as reported in the article)? When is the PEDI (Haley, Coster, Ludlow, Haltiwanger, & Andrellos, 1992) The child s function at home in self-care activities, mobility, and social function YES NO Not Reported Although the authors reported the PEDI to be reliable, they provided no further information. YES NO Not Reported The authors stated that the PEDI is valid, but they provided no further information. Pretreatment and posttreatment 5

6 measure used? Measure 2: COPM Name/type of measure used: What outcome is measured? Is the measure reliable as reported in the article? Is the measure valid as reported in the article? When is the measure used? COPM (Carswell et al., 2004). Changes in functional problems the parents consider to be relevant in the areas of self-care, productivity, and leisure performance YES NO Not Reported The authors stated that the COPM is reliable, but they provided no further information. YES NO Not Reported The authors stated that the COPM is valid, but they provided no further information. Pretreatment and posttreatment Measure 3: Functional goal performance scale Name/type of measure used: What outcome is measured? Is the measure reliable as reported in the article? Is the measure valid as reported in the article? When is the measure used? Functional goal performance scale Self-report measure to categorize types of goals and parent s perception NO Not Reported NO Not Reported Preintervention and postintervention MEASUREMENT BIASES 6

7 Were the evaluators blind to treatment status? The evaluator was not blinded to the groups or study objectives. Was there recall or memory bias? YES NO Both of the measures were interviews and depended on how the parents perceived their child s function and the importance of activities on the measures. Other measurement biases: The COPM was completed by the parents, because the children (the actual participants) were too young to answer the questions. RESULTS After treatment, both groups showed improvements on the evaluation of the PEDI self-care functional skills (p =.0001) with a large effect size (partial η 2 =.83), and significant improvement with a large effect size (p =.01, partial η 2 =.37) for independence. There was no significant difference between groups. Both groups improved in the performance section of the COPM, with a large effect size (p <.000, partial η 2 =.79). However, the HABIT group showed the greatest improvements (p =.04, partial η 2 =.27). Satisfaction scores on the COPM improved for both groups, with a large effect size (p =.0001, partial η 2 =.72). However, there was no difference between the groups. The authors performed an analysis of goal performance and satisfaction for goals that participants practiced and goals they did not practice as part of the interventions. Of the goals participants practiced as part of the assigned treatment protocol, both groups had statistically significant improvement in satisfaction (p =.003, partial η 2 =.65) and performance (p =.0001, partial η 2 =.84), with no significant differences between the groups. For goals participants did not practice as part of the assigned treatment protocol, both groups demonstrated statistically significant improvement in satisfaction (p =.0001, partial η 2 =.61) and performance (p =.0001, partial η 2 =.74), with no significant differences between the groups. Was this study adequately powered (large enough to show a difference)? Power analysis was not completed 7

8 Were the analysis methods appropriate? YES NO Normal distribution was established with the Shapiro Wilk test. The authors then compared the two groups scores using an analysis of variance (ANOVA). Additionally, they used ANOVAs to compare preintervention and postintervention assessments and to test group interactions. An ANOVA is appropriate because it is used to test the differences between two independent groups and two or more means (Rebar & Gersh, 2015). Were statistics appropriately reported (in written or table format)? YES NO The statistics were reported in a narrative form, and performance difference and satisfaction difference for individual scores were recorded in a table. Was participant dropout less than 20% in total sample and balanced between groups? YES NO No dropouts were reported. What are the overall study limitations? Study limitations include the following: The sample was not powered. The authors did not state whether the sample size was large enough to detect a difference. Measures were primarily parent driven, without child input. Outcome on arm function was not reported. Raters were not blinded to treatment allocation. There were more older children in the CIMT group than in the HABIT group. CONCLUSION Children with hemiplegia who received either CIMT or HABIT reported improvements in daily living activities. Children in the HABIT group showed greater improvements than children in the CIMT group only on the functional goal performance scale. This might suggest that practicing functional activities with two hands may lead to increased performance. Occupational therapists may choose CIMT or HABIT on the basis of their own expertise, the child s needs and interests, and characteristics of established client goals. However, all goals should be client centered. 8

9 Further research should include a powered sample, investigation of the long-term effects of the interventions, and a control group that receives no therapy or traditional therapy. This is recommended because this research was part of a larger study, and it was groundbreaking because it provided a dose of bimanual therapy that was equivalent to CIMT. One of the issues with CIMT is the question of whether the gains achieved are only because of increased dosing. References Carswell, A., McColl, M. A., Baptiste, S., Law, M., Polatajko, H., & Pollock, N. (2004). The Canadian Occupational Performance Measure: A research and clinical literature review. Canadian Journal of Occupational Therapy, 71, Haley, S. M., Coster, W., Ludlow, L. H., Haltiwanger, J. T., & Andrellos, P. J. (1992). Pediatric Evaluation of Disability Inventory: Development, standardization and administration manual. Boston: New England Medical Center. Jebsen, R. H., Taylor, N., Trieschmann, R. B., Trotter, M. J., & Howard, L. A. (1969). An objective and standardized test of hand function. Archives of Physical Medicine and Rehabilitation, 50, Rebar, C. R., & Gersh, C. J. (2015). Understanding research for evidence based practice (4th ed., pp ). Alphen on the Rhine, the Netherlands: Wolters Kluwer. Van Zelst, B. R., Miller, M. D., Russo, R. N., Murchland, S., & Crotty, M. (2006). Activities of daily living in children with hemiplegic cerebral palsy: A cross-sectional evaluation using the Assessment of Motor and Process Skills. Developmental Medicine and Child Neurology, 48,

10 This work is based on the evidence-based literature review completed by Leah Haller, OTR/L, and Alison Bell, OTD, OTR/L, Thomas Jefferson 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. For personal or educational use only. All other uses require permission from AOTA. Contact: 10