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Clinical Trials in Belgium / NCT06767930
Starting soon Not applicable

Effects of HABIT-ILE in Adults with Bilateral Cerebral Palsy

NCT06767930 · tracked via the Priya Life Science Belgium tracker
Sponsor
Université Catholique de Louvain
Phase
Not applicable
Started
2025-01-06
Last updated
2025-01-10

Condition(s) studied

Cerebral PalsyBilateral Cerebral Palsy

Investigational drug(s) / intervention(s)

Hand and Arm Bimanual Intensive Therapy Including Lower ExtremitiesConventional intervention

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.

Study summary

This randomized controlled trial (RCT) aims to evaluate the effects of intensive Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in improving body structure, function, daily activities, and participation outcomes among adults with cerebral palsy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Diagnosed bilateral cerebral palsy, * 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: * Unstable seizure * 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...)

Primary outcome measure(s)

  • Changes in Gross Motor Function Measurement (GMFM-66) — pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
    Measurement of change in gross motor function over time in adults with cerebral palsy.

Trial sites (1)

FacilityCityRegionStatus
Faculté des Sciences de la Motricité (UCLouvain) Louvain-la-Neuve Brabant-Wallon

More Université Catholique de Louvain trials in Belgium

Implementation of a HABIT-ILE Intervention at William Lennox Neurological Hospital (NeuREHA) - Adult Starting soon
Implementation of a HABIT-ILE Intervention at William Lennox Neurological Hospital (NeuREHA) Recruiting
Implementation of a HABIT-ILE Intervention at Home for Children With Bilateral Cerebral Palsy Recruiting
Birth Experience of Women Giving Birth in Belgium Recruiting
A Geriatric Mobile Team for Nursing Home Residents: a Feasibility Pilot Study Starting soon

Other trials for the same condition

Implementation of a HABIT-ILE Intervention at Home for Children With Bilateral Cerebral Palsy Recruiting
Eye-tracking Working Memory Training in Children and Youth With Severe Cerebral Palsy Active, not recruiting
Motor and Cognitive Functions in Acquired and Developmental Brain Damaged Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06767930 on ClinicalTrials.gov ↗ ← All trials in Belgium