Adam Kirton1, John Andersen2, Mia Herrero2, Alberto Nettel-Aguirre2, Lisa Carsolio2, Omar Damji2, Jamie Keess2, Aleksandra Mineyko2, Jacquie Hodge2, Michael D Hill2. 1. From the Departments of Pediatrics and Clinical Neurosciences (A.K., A.M.), Cumming School of Medicine, Alberta Children's Hospital Research Institute, University of Calgary; University of Alberta (J.A.), Glenrose Rehabilitation Hospital, Edmonton; Clinical Neurosciences (M.H., L.C.), Alberta Children's Hospital, Alberta Health Services; Department of Pediatrics (A.N.-A.) and Calgary Pediatric Stroke Program (A.K., O.D., J.K., A.M., J.H.), Alberta Children's Hospital; Hotchkiss Brain Institute (A.K., M.D.H.), Cumming School of Medicine, University of Calgary, Canada. adam.kirton@ahs.ca. 2. From the Departments of Pediatrics and Clinical Neurosciences (A.K., A.M.), Cumming School of Medicine, Alberta Children's Hospital Research Institute, University of Calgary; University of Alberta (J.A.), Glenrose Rehabilitation Hospital, Edmonton; Clinical Neurosciences (M.H., L.C.), Alberta Children's Hospital, Alberta Health Services; Department of Pediatrics (A.N.-A.) and Calgary Pediatric Stroke Program (A.K., O.D., J.K., A.M., J.H.), Alberta Children's Hospital; Hotchkiss Brain Institute (A.K., M.D.H.), Cumming School of Medicine, University of Calgary, Canada.
Abstract
OBJECTIVE: To determine whether the addition of repetitive transcranial magnetic stimulation (rTMS) and/or constraint-induced movement therapy (CIMT) to intensive therapy increases motor function in children with perinatal stroke and hemiparesis. METHODS: A factorial-design, blinded, randomized controlled trial (clinicaltrials.gov/NCT01189058) assessed rTMS and CIMT effects in hemiparetic children (aged 6-19 years) with MRI-confirmed perinatal stroke. All completed a 2-week, goal-directed, peer-supported motor learning camp randomized to daily rTMS, CIMT, both, or neither. Primary outcomes were the Assisting Hand Assessment and the Canadian Occupational Performance Measure at baseline, and 1 week, 2 and 6 months postintervention. Outcome assessors were blinded to treatment. Interim safety analyses occurred after 12 and 24 participants. Intention-to-treat analysis examined treatment effects over time (linear mixed effects model). RESULTS:All 45 participants completed the trial. Addition of rTMS, CIMT, or both doubled the chances of clinically significant improvement. Assisting Hand Assessment gains at 6 months were additive and largest with rTMS + CIMT (β coefficient = 5.54 [2.57-8.51], p = 0.0004). The camp alone produced large improvements in Canadian Occupational Performance Measure scores, maximal at 6 months (Cohen d = 1.6, p = 0.002). Quality-of-life scores improved. Interventions were well tolerated and safe with no decrease in function of either hand. CONCLUSIONS:Hemiparetic children participating in intensive, psychosocial rehabilitation programs can achieve sustained functional gains. Addition of CIMT and rTMS increases the chances of improvement. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that combined rTMS and CIMT enhance therapy-induced functional motor gains in children with stroke-induced hemiparetic cerebral palsy.
RCT Entities:
OBJECTIVE: To determine whether the addition of repetitive transcranial magnetic stimulation (rTMS) and/or constraint-induced movement therapy (CIMT) to intensive therapy increases motor function in children with perinatal stroke and hemiparesis. METHODS: A factorial-design, blinded, randomized controlled trial (clinicaltrials.gov/NCT01189058) assessed rTMS and CIMT effects in hemiparetic children (aged 6-19 years) with MRI-confirmed perinatal stroke. All completed a 2-week, goal-directed, peer-supported motor learning camp randomized to daily rTMS, CIMT, both, or neither. Primary outcomes were the Assisting Hand Assessment and the Canadian Occupational Performance Measure at baseline, and 1 week, 2 and 6 months postintervention. Outcome assessors were blinded to treatment. Interim safety analyses occurred after 12 and 24 participants. Intention-to-treat analysis examined treatment effects over time (linear mixed effects model). RESULTS: All 45 participants completed the trial. Addition of rTMS, CIMT, or both doubled the chances of clinically significant improvement. Assisting Hand Assessment gains at 6 months were additive and largest with rTMS + CIMT (β coefficient = 5.54 [2.57-8.51], p = 0.0004). The camp alone produced large improvements in Canadian Occupational Performance Measure scores, maximal at 6 months (Cohen d = 1.6, p = 0.002). Quality-of-life scores improved. Interventions were well tolerated and safe with no decrease in function of either hand. CONCLUSIONS: Hemiparetic children participating in intensive, psychosocial rehabilitation programs can achieve sustained functional gains. Addition of CIMT and rTMS increases the chances of improvement. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that combined rTMS and CIMT enhance therapy-induced functional motor gains in children with stroke-induced hemiparetic cerebral palsy.
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