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

Université Catholique de Louvain1 site in 1 country40 target enrollmentJanuary 6, 2025

ConditionsCerebral Palsy Bilateral Cerebral Palsy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cerebral Palsy
Sponsor: Université Catholique de Louvain
Enrollment: 40
Locations: 1
Primary Endpoint: Changes in Gross Motor Function Measurement (GMFM-66)
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 6, 2025

End Date

December 31, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Université Catholique de Louvain

Responsible Party

Principal Investigator

Yannick Bleyenheuft

Professor

Université Catholique de Louvain

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...)

Outcomes

Primary Outcomes

Changes in Gross Motor Function Measurement (GMFM-66)

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

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

Secondary Outcomes

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)
Changes in the 2-Minutes' Walk Test (2MWT)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in spinal function (electromyography - EMG)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in pain perception (Quantitative Sensory Testing - QST)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in daily pain perception (Ecological Moment Assessment)(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)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in neuropathic pain (PROMIS PQ-Neuro)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in perception of pain (Pain Catastrophizing Scale - PCS)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in coping strategies (Coping Strategies Questionnaire - CSQ-F)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in coping strategies (General Self-Efficacy Scale - GSES)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in daily activities (Canadian Occupational Performance Measure - COPM)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in daily activities (ABILHAND Questionnaire)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in daily activities (ACTIVLIM-CP Questionnaire)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in daily activities (ABILOCO questionnaire)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in participation (Participation in Life Situation Questionnaire - PILS)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in psychological well-being (Hospital Anxiety and Depression Scale - HADS)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in pain and sleeping (Pain and Sleep Questionnaire 3 - PSQ-3)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in fatigue (Multidimensional Fatigue Inventory - MFI)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in quality of life (WHOQOL-BREF)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
Changes in cognitive function (PROMIS Neuro-QOL Short Form Cognitive Function 2.0)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)