Constraint-Induced Movement Therapy for Cerebral Palsy: A Randomized Trial

Abstract

Objectives: With the Children with Hemiparesis Arm and Hand Movement Project (CHAMP) multisite factorial randomized controlled trial, we compared 2 doses and 2 constraint types of constraint-induced movement therapy (CIMT) to usual customary treatment (UCT).

Methods: CHAMP randomly assigned 118 2- to 8-year-olds with hemiparetic cerebral palsy to one of 5 treatments with assessments at baseline, end of treatment, and 6 months posttreatment. Primary blinded outcomes were the assisting hand assessment; Peabody Motor Development Scales, Second Edition, Visual Motor Integration; and Quality of Upper Extremity Skills Test Dissociated Movement. Parents rated functioning on the Pediatric Evaluation of Disabilities Inventory-Computer Adaptive Test Daily Activities and Child Motor Activity Log How Often scale. Analyses were focused on blinded and parent-report outcomes and rank-order gains across all measures.

Results: Findings varied in statistical significance when analyzing individual blinded outcomes. parent reports, and rank-order gains. Consistently, high-dose CIMT, regardless of constraint type, produced a pattern of greatest short- and long-term gains (1.7% probability of occurring by chance alone) and significant gains on visual motor integration and dissociated movement at 6 months. O'Brien's rank-order analyses revealed high-dose CIMT produced significantly greater improvement than a moderate dose or UCT. All CIMT groups improved significantly more in parent-reported functioning, compared with that of UCT. Children with UCT also revealed objective gains (eg, 48% exceeded the smallest-detectable assisting hand assessment change, compared with 71% high-dose CIMT at the end of treatment).

Conclusions: CHAMP provides novel albeit complex findings: although most individual blinded outcomes fell below statistical significance for group differences, high-dose CIMT consistently produced the largest improvements at both time points. An unexpected finding concerns shifts in UCT toward higher dosages, with improved outcomes compared with previous reports.

Trial registration: ClinicalTrials.gov NCT01895660.

FIGURE 1

Consolidated Standards of Reporting Trials diagram for CHAMP 2 × 2 factorial RCT of variations in CIMT dose and constraint type.

FIGURE 2

Primary blinded outcomes for CHAMP treatment groups at end of treatment (left bar) and 6 months posttreatment (right bar with outline). Means and SEs for groups for PMDS-2 VM and QUEST DM reflect gains since the baseline. In Table 1, we provide baseline scores so that final scores can be calculated by adding gain scores. In Table 2, we provide results of statistical analyses contrasting manipulated factors of Dose and Constraint to UCT. Grey indicates UCT; yellow indicates 30-hour moderate-dose CIMT; green indicates 60-hour high-dose CIMT; solid nongrey colors indicate full-time cast; dots indicate part-time splint; no outline indicates end of treatment; black outline indicates 6 months posttreatment. A, AHA: percentage with gain of ≥5 logit points. B, AHA: mean changes (SE) from the baseline. C, VMI (affected side): mean changes (SE) from baseline. D, QUEST Disassociated Movement (affected side): mean changes from baseline.

FIGURE 3

Primary parent-reported functional outcomes for CHAMP treatment groups at end of treatment (left bar) and 6 months posttreatment (right bar with black outline). Means and SEs for Groups for CMAL how often and PEDI-CAT Daily Activities reflect gains since the baseline. In Table 1, we provide baseline scores so that final scores can be calculated by adding gain scores. In Table 2, we provides results of statistical analyses contrasting manipulated factors of dose and constraint to UCT. Grey indicates UCT; yellow indicates 30-hour moderate-dose CIMT; green indicates 60-hour high-dose CIMT; solid nongrey colors indicate full-time cast; dots indicate part-time splint; no outline indicates end of treatment; black outline indicates 6-mo posttreatment. A, AHA: percentage with gain of ≥5 logit points. B, AHA: mean changes (SE) from the baseline. A, CMAL How Often. B, PEDI-CAT Daily Activities.

FIGURE 4

O’Brien’s composite rank-order outcomes for CHAMP treatment groups at end of treatment and 6-months posttreatment. Panels A and C demarcate the lowest rank of a child in the group, the first quartile, the median group rank-order value, the third quartile, and the highest rank of a child in the group. Sections B and D reveal 95% CIs for contrasts of factors compared with UCT. A, end of treatment. B, end of treatment. C, 6 months posttreatment. D, 6 months posttreatment.