Effects of HABIT-ILE in Adults with Bilateral Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities, Conventional intervention.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy, Bilateral Cerebral Palsy. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Adults with Bilateral Cerebral Palsy
Overview
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.
Interventions
- 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 particip - 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.
Primary outcome measures
- Changes in Gross Motor Function Measurement (GMFM-66) [Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
Secondary outcome measures (12)
- Changes in muscle strength (Biodex System 4 pro®) [Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
- Changes in muscle strength (Jamar) [Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
- Changes in muscle range of motion (Biodex System 4 pro®) [Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
- Changes in neuromuscular command (muscle co-contraction) [Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
- Changes in unimanual dexterity (Box and Blocks Test - BBT) [Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
- Changes in the 2-Minutes' Walk Test (2MWT) [Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
- Changes in spinal function (electromyography - EMG) [Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
- Changes in pain perception (Quantitative Sensory Testing - QST) [Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
- Changes in daily pain perception (Ecological Moment Assessment) [Time frame: Pre-intervention (1 week before), during intervention (camp or control period), post-intervention (1 week after), 3 months follow-up]
- Changes in severity of pain (Brief Pain Inventory - Short Form - BPI-SF) [Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
- Changes in neuropathic pain (PROMIS PQ-Neuro) [Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
- Changes in perception of pain (Pain Catastrophizing Scale - PCS) [Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
Eligibility criteria
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...)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Faculté des Sciences de la Motricité (UCLouvain) — Louvain-la-Neuve
Identifiers
NCT: NCT06767930 · B403201316810i