Effects of HABIT-ILE in Adults with Bilateral Cerebral Palsy

Université Catholique de Louvain

Status: Not yet enrolling

Conditions: Cerebral Palsy; Bilateral Cerebral Palsy

Treatments: Behavioral: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities; Behavioral: Conventional intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06767930

B403201316810i

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

HABIT-ILE

Experimental group

Treatment:

Behavioral: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities

Conventional intervention

Active Comparator group

Treatment:

Behavioral: Conventional intervention