Protocol for N-of-1 trials with replications across therapists for childhood-onset dystonia rehabilitation: Study 2: Protocole des essais à effectif unique avec répétitions par différents ergothérapeutes pour la réadaptation de la dystonie débutant dans l'enfance : Étude 2.

BACKGROUND: Currently, no evidence-based rehabilitation interventions are available for hyperkinetic movement disorders (HMD), including dyskinetic cerebral palsy (CP). Among these highly heterogeneous disorders, dystonia is the predominant disorder. The Cognitive Orientation to daily Occupational Performance (CO-OP) Approach-a task-oriented, performance-based intervention to enable participation-is currently being evaluated for its potential as an intervention option.

PURPOSE: This paper reports the protocol for the second of two studies designed to evaluate the potential of CO-OP to improve functional outcomes for individuals with HMD following deep brain stimulation (DBS). This second study is a systematic replication across multiple treating therapists from multiple centres.

METHOD: Systematic replications will be used across centres and treating therapists trained in the CO-OP, using a series of randomized multiple-baseline N-of-1 trials. Participants will be ages 6 to 21 years with HMD and DBS as indicated by the Manual Ability Classification System. Data collection will involve multiple data points collected at baseline, during intervention, and after intervention. The intervention will involve occupation-based goal setting followed by 10 individualized CO-OP sessions. The primary outcome measures are the Performance Quality Rating Scale and the Canadian Occupational Performance Measure. Outcome data will be plotted over time for each participant and supplemented with graph statistical analysis and estimate size effect for N-of-1 trials.

IMPLICATIONS: The results of this study will help to inform future training procedures and future clinical trials.