Aim Conventional constraint‐based therapies are intensive and demanding to implement, particularly for children. Modified forms of constraint‐based therapies that are family‐centred may be more acceptable and feasible for families of children with cerebral palsy (CP)‐but require rigorous evaluation using randomized trials. The aim of this study was to determine the effects of modified constraint‐induced therapy compared with intensive occupational therapy on activities of daily living and upper limb outcomes in children with hemiplegic CP.
Method In this assessor‐blinded pragmatic randomized trial, 50 children (27 males, 23 females; age range 19mo–7y 10mo) with hemiplegic CP were randomized using a concealed allocation procedure to one of two 8‐week interventions: intensive occupational therapy (n=25), or modified constraint‐induced therapy (n=25). Manual Ability Classification System (MACS) levels of the participants were, level I n=2, II n=37, III n=8, and level IV n=1; Gross Motor Function Classification System (GMFCS) levels were, level I n=33, level II n=15, and level III n=1. Participants were recruited through three specialist CP centres in Australia and randomized between January 2008 and April 2010. Children randomized to modified constraint‐induced therapy wore a mitt on the unaffected hand for 2 hours each day, during which time the children participated in targeted therapy. The primary outcome was the Canadian Occupational Performance Measure (COPM – measured on a 10‐point scale) at completion of therapy. Other outcome measures were Goal Attainment Scaling, Assisting Hand Assessment, Pediatric Motor Activity Log, Modified Ashworth Scale, Modified Tardieu Scale, and a parent questionnaire. Assessments were carried out at 10 weeks and 6 months following randomization.
Results All participants were included in the analysis. Between‐group differences for all outcomes were neither clinically important nor statistically significant. The mean difference in COPM was 0.3 (95% confidence interval [CI] −0.8 to 1.4; p=0.61) and mean difference in COPM satisfaction was 0.1 (95% CI −1.1 to 1.2; p=0.90). Minor adverse events were reported by five of the 25 participants in the modified constraint‐induced therapy group and by one of the 25 in the intensive occupational therapy group. All adverse events were related to participants’ lack of acceptance of therapy.
Interpretation Modified constraint‐induced therapy is no more effective than intensive occupational therapy for improving completion of activities of daily living or upper limb function in children with hemiplegic CP.
The Pediatric Motor Activity Log (PMAL) is a parent‐report measure of the use, by children with hemiplegic cerebral palsy (CP), of their affected upper limb in everyday activities. The aim of this study was to examine the psychometric properties of both scales of the PMAL (‘How Often’ and ‘How Well’ scales) using Rasch measurement modelling. Sixty‐one parents of children with hemiplegic CP completed the PMAL and 31 completed it again 3 weeks later. The mean age of children was 4 years 6 months (SD 1y 9mo); 35 males, 26 females. Children were at Gross Motor Function Classification System (GMFCS) levels I (83%) and II (17%), and Manual Ability Classification System levels I (35%), II (52%), and III (14%). The original scales were found to have disordered rating scale structure. Further Rasch modelling with collapsed rating scale structures resulted in both scales conforming to the expectations of the Rasch model, yielding strong evidence for construct validity and reliability. One item from the How Often scale failed to conform to Rasch expectations and was deleted in subsequent analyses. Test–retest reliability of both scales was high (the intraclass correlation coefficient for the How Often scale was 0.94, and for the How Well scale 0.93). The revised scales possess good psychometric properties, specifically a logical item hierarchy, evidence of unidimensionality, adequate rating scale structure, and good test–retest reliability. We conclude that the revised PMAL has the capacity to yield valid and reliable scores except for children at the extremes of upper limb ability.
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