Clinical trial NCT06767930: Effects of HABIT-ILE in Adults with Bilateral Cerebral Palsy
Official title: Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Adults with Bilateral Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Paris 12 Val de Marne University
First posted: 2025-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

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...)

Primary outcomes:
measure: Changes in Gross Motor Function Measurement (GMFM-66)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Secondary outcomes:
measure: Changes in muscle strength (Biodex System 4 pro®)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in muscle strength (Jamar)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in muscle range of motion (Biodex System 4 pro®)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in neuromuscular command (muscle co-contraction)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in unimanual dexterity (Box and Blocks Test - BBT)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in the 2-Minutes' Walk Test (2MWT)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in spinal function (electromyography - EMG)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in pain perception (Quantitative Sensory Testing - QST)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in daily pain perception (Ecological Moment Assessment)
timeFrame: Pre-intervention (1 week before), during intervention (camp or control period), post-intervention (1 week after), 3 months follow-up
measure: Changes in severity of pain (Brief Pain Inventory - Short Form - BPI-SF)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in neuropathic pain (PROMIS PQ-Neuro)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in perception of pain (Pain Catastrophizing Scale - PCS)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in coping strategies (Coping Strategies Questionnaire - CSQ-F)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in coping strategies (General Self-Efficacy Scale - GSES)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in daily activities (Canadian Occupational Performance Measure - COPM)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in daily activities (ABILHAND Questionnaire)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in daily activities (ACTIVLIM-CP Questionnaire)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in daily activities (ABILOCO questionnaire)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in participation (Participation in Life Situation Questionnaire - PILS)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in psychological well-being (Hospital Anxiety and Depression Scale - HADS)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in pain and sleeping (Pain and Sleep Questionnaire 3 - PSQ-3)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in fatigue (Multidimensional Fatigue Inventory - MFI)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in quality of life (WHOQOL-BREF)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
measure: Changes in cognitive function (PROMIS Neuro-QOL Short Form Cognitive Function 2.0)
timeFrame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Other outcomes:
Locations:
city: Louvain-La-Neuve
country: Belgium
facility: Faculté des Sciences de la Motricité (UCLouvain)
state: Brabant-Wallon
Study officials:
References: