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Let's CO-OPerate! Together we Are Stronger

H

Hopitaux de Saint-Maurice

Status

Begins enrollment this month

Conditions

Acquired Brain Injury (Including Stroke)
Developmental Coordination Disorder
Executive Function Deficits (EFD)
Brain Injury, Fetus and Neonate

Treatments

Other: Cognitive Orientation to daily Occupational Performance (CO-OP) is a cognitive problem-solving approach

Study type

Interventional

Funder types

Other

Identifiers

NCT07085403
COOPerons - PR- 2024 - 7

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

8 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children/adolescents (aged 8-16) with a diagnose of developmental coordination disorders and/or executive function deficits following an acquired or congenital brain injury;
  • Vision and hearing normal or sufficient to communicate effectively (with appropriate correction where necessary);
  • Having sufficient speaking and listening skills to communicate effectively and accurately;
  • Agreement of the child/adolescent (aged 8-17) and informed consent expressed by one of the holders of parental authority.

Exclusion criteria

  • Children who do not meet the inclusion criteria.
  • Children whose parents do not have a sufficient knowledge of the French language to take part in the project.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

COOP experimental arm
Experimental group
Treatment:
Other: Cognitive Orientation to daily Occupational Performance (CO-OP) is a cognitive problem-solving approach

Trial contacts and locations

1

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Central trial contact

Helene LEBRAULT, OT, PhD

Data sourced from clinicaltrials.gov

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