Effects of HABIT-ILE in Adults with Bilateral Cerebral Palsy

NCT06767930 | Not Yet Recruiting DMC

• 1 other identifier: B403201316810i
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy; Bilateral Cerebral Palsy

Keywords

cerebral palsy; motor skill learning; intensive therapy; body function; body structure; muscle structure; pain; activities; quality of life; adults

Outcome Measures

Primary Outcomes (1)

• Changes in Gross Motor Function Measurement (GMFM-66)

  Measurement of change in gross motor function over time in adults with cerebral palsy.

  pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up

Secondary Outcomes (24)

• Changes in muscle strength (Biodex System 4 pro®)

  pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up

• Changes in muscle strength (Jamar)

  pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up

• Changes in muscle range of motion (Biodex System 4 pro®)

  pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up

• Changes in neuromuscular command (muscle co-contraction)

  pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up

• Changes in unimanual dexterity (Box and Blocks Test - BBT)

  pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up

Study Arms (2)

HABIT-ILE

EXPERIMENTAL

Behavioral: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities

Conventional intervention

ACTIVE COMPARATOR

Behavioral: Conventional intervention

Interventions

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities BEHAVIORAL

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.

HABIT-ILE

Conventional intervention BEHAVIORAL

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.

Conventional intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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...)

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• Paris 12 Val de Marne University: collaborator

Study Sites (1)

Faculté des Sciences de la Motricité (UCLouvain)

Louvain-la-Neuve, Brabant-Wallon, 1348, Belgium

Location

MeSH Terms

Conditions

Cerebral Palsy; Pain; Motor Activity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Yannick Bleyenheuft, Professor

CONTACT

+3227649349; yannick.bleyenheuft@uclouvain.be

Elisa Vancolen, PhD student

CONTACT

+32473256219; elisa.vancolen@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The trial will be a single-blind, randomized controlled trial. Participants will be randomly assigned to one of two groups: a control group receiving conventional therapy or a treatment group participating in the HABIT-ILE therapy program. Longitudinal assessments will be conducted the week before the intervention, at the end of the two-week intervention and three months post-intervention.

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 10, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)