Effects of HABIT-ILE in Adults with Bilateral Cerebral Palsy
NCT ID: NCT06767930
Last Updated: 2025-01-10
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
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-01-06
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HABIT-ILE
Hand and Arm Bimanual Intensive Therapy Including Lower Extremities
The HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) program is an intensive rehabilitation therapy designed to improve motor functions and promote functional independence. Participants in this arm will engage in 6.5 hours of structured activities per day for two weeks (10 days). The therapy focuses on bimanual coordination combined with constant stimulation of the trunk and/or lower extremities, using task-oriented exercises tailored to individual goals. Each participant will be supported by one or two therapists and supervised by a trained team to ensure the program is delivered effectively and safely. The therapy emphasizes engaging, play-based activities to maximize motivation and active participation.
Conventional intervention
Conventional intervention
Participants in the control group will continue their usual care, which includes conventional physical and occupational therapy, for a duration of two weeks. They will follow their regular therapy schedules without any changes to their routines or treatment habits. This approach ensures that the control group reflects standard rehabilitation practices, allowing for a direct comparison with the intervention group.
Interventions
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Hand and Arm Bimanual Intensive Therapy Including Lower Extremities
The HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) program is an intensive rehabilitation therapy designed to improve motor functions and promote functional independence. Participants in this arm will engage in 6.5 hours of structured activities per day for two weeks (10 days). The therapy focuses on bimanual coordination combined with constant stimulation of the trunk and/or lower extremities, using task-oriented exercises tailored to individual goals. Each participant will be supported by one or two therapists and supervised by a trained team to ensure the program is delivered effectively and safely. The therapy emphasizes engaging, play-based activities to maximize motivation and active participation.
Conventional intervention
Participants in the control group will continue their usual care, which includes conventional physical and occupational therapy, for a duration of two weeks. They will follow their regular therapy schedules without any changes to their routines or treatment habits. This approach ensures that the control group reflects standard rehabilitation practices, allowing for a direct comparison with the intervention group.
Eligibility Criteria
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Inclusion Criteria
* Adults aged 18 to 50 years old,
* Level of manual ability : level I to V of MACS
* Level of gross motor function : level I to IV of GMFCS
* Ability to follow instructions and complete testing,
* Ability to walk 10 meters independently without human assistance (technical aids such as orthoses or walking aids are permitted).
Exclusion Criteria
* Programmed botulinum toxin or orthopedic surgery in the 6 months before the intervention, during intervention period or 6 months after the intervention time
* Alcohol/drug abuse
* Pregnancy
* Severe visual or cognitive (severe aphasia, psychiatric conditions) impairments likely to interfere with intervention or testing session completion
* Uncontrolled health issues (cardiac, metabolic...)
18 Years
50 Years
ALL
Yes
Sponsors
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Paris 12 Val de Marne University
OTHER
Université Catholique de Louvain
OTHER
Responsible Party
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Yannick Bleyenheuft
Professor
Locations
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Faculté des Sciences de la Motricité (UCLouvain)
Louvain-la-Neuve, Brabant-Wallon, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B403201316810i
Identifier Type: -
Identifier Source: org_study_id
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