Protocol: Using Single-Case Experimental Design to Evaluate Whole-Body Dynamic Seating on Activity, Participation,...

Introduction: People with hyperkinetic movement disorders, including dystonia, experience often painful, involuntary movements affecting functioning. Seating comfort is a key unmet need identified by families. This paper reports a protocol to assess the feasibility and preliminary evidence for the efficacy of dynamic seating to improve functional outcomes for young children with dystonic cerebral palsy (DCP). Design: A series of single-case experimental design N-of-1 trials, with replications across participants, with a random baseline interval, and one treatment period (n = 6). Methods: Inclusion criteria: DCP; 21.5 cm < popliteal fossa to posterior sacrum < 35 cm; Gross Motor Function Classification System level IV-V; mini-Manual Ability Classification System level IV-V; difficulties with seating. Intervention: Trial of the seat (8 weeks), with multiple baseline before, during and after intervention and 2 month follow up. The baseline duration will be randomised per child (2-7 weeks). Primary outcomes: Performance Quality Rating Scale; Canadian Occupational Performance Measure; seating tolerance. The statistician will create the randomization, with allocation concealment by registration of participants prior to sending the allocation arm to the principal investigator. Primary outcomes will be assessed from video by an assessor blind to allocation. Analysis: Participant outcome data will be plotted over time, with parametric and non-parametric analysis including estimated size effect for N-of-1 trials.