Intensive Rehabilitation Program for Upper Limb in Children and Adolescents With Cerebral Palsy
NCT ID: NCT07285837
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
90 participants
INTERVENTIONAL
2025-11-21
2030-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The French National Authority for Health has issued recommendations for intensifying rehabilitation in order to maximize functional gains in children with CP. Among the intensive approaches that have been studied, two techniques have demonstrated efficacy: Constraint-Induced Movement Therapy (CIMT) and Bimanual Intensive Therapy (BIT).
CIMT focuses on restricting the use of the unaffected limb to encourage the use of the affected limb, thereby promoting neuroplasticity and functional improvement. In contrast, BIT emphasizes intensive training of both hands simultaneously to enhance coordination and overall upper limb functionality.
At the Ellen Poidatz Foundation, an intensive rehabilitation program has been developed that combines these two complementary approaches. This program, which is already in place, is based on the principles of neuromotor rehabilitation and motor learning. It integrates several methods recommended by the HAS, including Bimanual Intensive Therapy (BIT) such as HABIT (Grade A) or HABIT-ILE (Grade B), Modified Constraint-Induced Movement Therapy (mCIMT) (Grade B), and Adapted Physical Activity (APA) (Grade A).
The aim of this intensive program is to enhance the functional use of the upper limb by improving bimanual coordination, grasping, manipulation, and overall motor function. The program lasts 10 days over a 2-week period and is tailored to the child's age and care setting. It includes approximately 60 hours of rehabilitation for children aged 4 to 8 years and 80 hours for those aged 9 to 17 years, in line with current international recommendations.
The aim of this study is to evaluate the effectiveness of this existing intensive rehabilitation program in improving manual abilities in children with CP. Specifically, the study seeks to objectively assess the benefits of the Habil'Hand+ program and to contribute to the optimization of rehabilitation protocols for this population.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CP children and adolescents
The program is tailored to the child's age and care setting. Children aged 4 to 8 years : 2 weeks program over 10 days with a total of 60 hours of CIMT+ BIT in a day-hospital setting.
Adolescents aged 9 to 17 years in day-hospital care : 2 weeks program over 10 days with a total of 80 hours of CIMT+ BIT in a day-hospital setting.
Adolescents aged 9 to 17 years in inpatient care : 2 weeks program over 10 days with a total of 80 hours of CIMT+ BIT in inpatient care.
Intensive Rehabilitation
Children aged 4 to 8 years : 2 weeks program over 10 days including two individual sessions and three group sessions per participant per day combining CIMT and BIT.
Adolescents aged 9 to 17 years in day-hospital care/ in inpatient care: 2 weeks program over 10 days including two individual sessions and three group sessions per participant per day combining CIMT and BIT.
Daily routines, and activities involve functional and playful motor tasks of progressively increasing difficulty.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intensive Rehabilitation
Children aged 4 to 8 years : 2 weeks program over 10 days including two individual sessions and three group sessions per participant per day combining CIMT and BIT.
Adolescents aged 9 to 17 years in day-hospital care/ in inpatient care: 2 weeks program over 10 days including two individual sessions and three group sessions per participant per day combining CIMT and BIT.
Daily routines, and activities involve functional and playful motor tasks of progressively increasing difficulty.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged between 4 and 17 years inclusive (\<18 years)
* Global Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS) levels I to IV
* Ability to cooperate, understand and follow simple instructions
* Patient affiliated to the French social security system
* Voluntary patient whose parents have given their consent for their child to participate in the study.
Exclusion Criteria
* Presence of behavioral disorders
* History of botulinum toxin injections or surgical intervention within six months prior to study enrollment.
4 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondation Ellen Poidatz
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fondation Ellen Poidatz
Saint-Fargeau-Ponthierry, Île-de-France Region, France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Fondation Ellen Poidatz Habil'Hand+
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Habil'Hand+
Identifier Type: -
Identifier Source: org_study_id