NCT07285837 Intensive Rehabilitation Program for Upper Limb in Children and Adolescents With Cerebral Palsy
| NCT ID | NCT07285837 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ellen Poidatz |
| Condition | Cerebral Palsy (CP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-11-21 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-11-21 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cerebral palsy is the most common motor disability in children. Individuals with CP often experience significant difficulties in the use of their upper limbs, which affects their autonomy and quality of life. Conventional rehabilitation, although essential, is often insufficient to compensate for these deficits in a meaningful way. 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 3 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.
Eligibility Criteria
Inclusion Criteria: * A clinical diagnosis of CP mentioned in the medical record * Aged between 3 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 injuries incompatible with participation in the program, or pain rated \>3 on the Visual Analogue Scale (VAS) * Presence of behavioral disorders * History of botulinum toxin injections or surgical intervention within six months prior to study enrollment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07285837 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Cerebral Palsy (CP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07285837 currently recruiting?
Yes, NCT07285837 is actively recruiting participants. Contact the research team at eric.desailly@fondationpoidatz.com for enrollment information.
Where is the NCT07285837 trial being conducted?
This trial is being conducted at Saint-Fargeau-Ponthierry, France.
Who is sponsoring the NCT07285837 clinical trial?
NCT07285837 is sponsored by Fondation Ellen Poidatz. The trial plans to enroll 90 participants.
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