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A biofeedback-enhanced therapeutic exercise video game intervention for young people with cerebral palsy: a randomized single-case experimental design feasibility study |
MacIntosh A, Desailly E, Vignais N, Vigneron V, Biddiss E |
PLoS ONE 2020 Jun;15(6):e0234767 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
IMPORTANCE/BACKGROUND: Movement-controlled video games have potential to promote home-based practice of therapy activities. The success of therapy gaming interventions depends on the quality of the technology used and the presence of effective support structures. AIM: This study assesses the feasibility of a novel intervention that combines a co-created gaming technology integrating evidence-based biofeedback and solution-focused coaching (SFC) strategies to support therapy engagement and efficacy at home. METHODS: Following feasibility and single-case reporting standards (CONSORT and SCRIBE), this was a non-blind, randomized, multiple-baseline, AB, design. Nineteen (19) young people with cerebral palsy (8 to 18 years old) completed the 4-week home-based intervention in France and Canada. Participant motivations, personalized practice goals, and relevance of the intervention to daily activities were discussed in a Solution Focused Coaching-style conversation pre-, post-intervention and during weekly check-ins. Participants controlled a video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software). Process feasibility success criteria for recruitment response, completion and adherence rates, and frequency of technical issues were established a priori. Scientific feasibility, effect size estimates and variance were determined for Body Function outcome measures: active wrist extension, grip strength and Box and Blocks Test; and for Activities and Participation measures: Assisting Hand Assessment (AHA), Canadian Occupational Performance Measure (COPM) and Self-Reported Experiences of Activity Settings (SEAS). RESULTS: Recruitment response (31%) and assessment completion (84%) rates were good and 74% of participants reached self-identified practice goals. As 17% of technical issues required external support to resolve, the intervention was graded as feasible with modifications. No adverse events were reported. Moderate effects were observed in Body Function measures (active wrist extension SMD 1.82, 95%CI 0.85 to 2.78; grip strength SMD 0.63, 95%CI 0.65 to 1.91; Box and Blocks Hedge's g 0.58, 95%CI -0.11 to 1.27) and small-moderate effects in activities and participation measures (AHA Hedge's g 0.29, 95%CI -0.39 to 0.97, COPM r = 0.60, 95%CI 0.13 to 0.82, SEAS r = 0.24, 95%CI -0.25 to 0.61). CONCLUSION: A definitive RCT to investigate the effectiveness of this novel intervention is warranted. Combining SFC-style coaching with high-quality biofeedback may positively engage youth in home rehabilitation to complement traditional therapy. TRIAL REGISTRATION: ClinicalTrials.gov US National Library of Medicine NCT03677193.
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