Clinical Trial

Let's CO-OPerate! Together we Are Stronger

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Summary
The goal of this replicated single case experimental study using a randomized multiple baseline design across participants and goals is to enable children/adolescents (aged 8-16 years) with developmental coordination disorders and/or executive function deficits following an acquired or congenital brain injury, to achieve their occupational goals. The aim is to make them more independents and autonomous in their daily lives. To achieve this, we're going to offer them an intensive group CO-OP (Cognitive Orientation to daily Occupational Performance Approach) rehabilitation training, and actively involving the parents. The main questions it aims to answer are: * To evaluate the improvement in occupational performance\* (and its maintenance over time) following intervention using the CO-OP Approach. \*Occupational performance is a person's ability to choose, organize and engage in meaningful occupations that give them satisfaction. These occupations, determined by culture and corresponding to their age group, enable them to take care of themselves, have fun and contribute to the social and economic fabric of the community. * To gather parents' experiences of supporting their child during the CO-OP intervention and its follow-up phase. Participants will be asked to identify 3 goals that they would like to achieve with the CO-OP Approach. The CO-OP intervention will take the form of two half-days a week for 5 weeks, with 1 hour 30 minutes of individual CO-OP sessions and 1 hour 30 minutes of group sessions.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-17.
Trial Details
NCT Number NCT07085403
Lead Sponsor Hopitaux de Saint-Maurice
Conditions Executive Function Deficits (EFD), Developmental Coordination Disorder, Acquired Brain Injury (Including Stroke), Brain Injury, Fetus and Neonate
Enrollment 12 participants
Start Date 2025-09-01
Primary Completion 2027-05-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-13