NCT06767930

Effects of HABIT-ILE in Adults with Bilateral Cerebral Palsy

Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Adults with Bilateral Cerebral Palsy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This randomized controlled trial (RCT) will investigate the impact of two weeks of HABIT-ILE therapy versus conventional rehabilitation on spinal, muscular, and functional outcomes in adults (18-50 years old) with bilateral cerebral palsy (CP). Key assessments will include changes in gross motor function, spinal and muscular adaptations assessed via EMG and ultrasound, strength testing, clinical motor function tests, pain assessment, and questionnaires on activity and participation. This study aims to provide a comprehensive analysis of HABIT-ILE's effects especially on motor function, daily life activities and participation across a wide range of age.

Conditions

• Cerebral Palsy
• Bilateral Cerebral Palsy

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-01-06
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2025-01-10
• Last updated: 2025-01-10

Locations

1 site across 1 country: Belgium