Functional, Neuroplastic and Biomechanical Changes Induced by Early Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Pre-school Children With Uni- and Bilateral Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 5
- Primary Endpoint
- Change on Manual Ability (Assisting Hand Assessment (AHA))
Study Overview
Brief Summary
Studying in two randomized controlled trials (RCT) the changes induced by early HABIT-ILE in functional, neuroplastic and biomechanical assessment in children with unilateral and bilateral CP.
Detailed Description
This study aims to evaluate the effect of two weeks of early Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on bimanual performance in pre-school children with unilateral cerebral palsy (CP) and on gross motor function in those with bilateral CP, compared with two weeks of usual motor activity including usual rehabilitation (control group). We will assess further changes in unilateral performance tests, daily life activities questionnaires and executive function tests. Neuroplastic changes will be assessed using brain imaging (magnetic resonance imaging, MRI) and biomechanical changes will be assessed by using optoelectronic motion capture system with electromyography (EMG), to determine the effect of HABIT-ILE on movement pattern and quality.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Months to 59 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •children with unilateral or bilateral cerebral palsy (spastic or dyskinetic)
- •age 1 to 4 years inclusive (corrected age if preterm birth)
- •ability to follow instructions and complete testing according to the age.
Exclusion Criteria
- •active seizure
- •programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time
- •severe visual impairments
- •severe cognitive impairments
- •contraindications to perform MRI assessments (Metal implants, etc.)
Outcomes
Primary Outcomes
Change on Manual Ability (Assisting Hand Assessment (AHA))
Time Frame: pre-camp, two weeks post-camp, 3 months follow-up
Developed to observe the efficacy of the assisting hand use, in children with unilateral cerebral palsy (scored in percentage), during bimanual activities for the first randomized controlled trial (RCT1)
Change on Gross Motor Function (GMFM-66)
Time Frame: pre-camp, two weeks post-camp, 3 months follow-up.
Developed to assess the changes in gross motor function of children with cerebral palsy (scored in percentage), observed over time or after intervention for the second randomized controlled trial (RCT2)
Secondary Outcomes
- Melbourne 2 Assessment (MA2)(pre-camp, two weeks post-camp, 3 months follow-up)
- Measure of Processes of Care (MPOC-20)(pre-camp, two weeks post-camp, 3 months follow-up)
- 3D T1-weighted structural imaging (T1)(pre-camp, 3 months follow-up)
- Semmes-Weinstein monofilaments(pre-camp, two weeks post-camp, 3 months follow-up)
- Pressure Threshold(pre-camp, two weeks post-camp, 3 months follow-up)
- Young children's participation and environment measure (YC-PEM)(pre-camp, two weeks post-camp, 3 months follow-up)
- Inhibitory control task(pre-camp, two weeks post-camp, 3 months follow-up)
- Working memory task(pre-camp, two weeks post-camp, 3 months follow-up)
- Visuo-spatial attention assessment(pre-camp, two weeks post-camp, 3 months follow-up)
- Activlim-CP questionnaire(pre-camp, two weeks post-camp, 3 months follow-up)
- Changes on the Fractional Anisotropy (Diffusion tensor imaging (DTI))(pre-camp, 3 months follow-up)
- Changes on temporal parameters of the gait (Stride)(pre-camp, 3 months follow-up)
- Changes on temporal parameters of the gait (Velocity)(pre-camp, 3 months follow-up)
- Changes on temporal parameters of the upper extremity (Kinematics assessments)(pre-camp, 3 months follow-up)
- Changes on spatial parameters of the upper extremity (Straightness)(pre-camp, 3 months follow-up)
- Canadian Occupational Performance Measure (COPM)(pre-camp, two weeks post-camp, 3 months follow-up)
- Changes on resting state functional connectivity (RS)(pre-camp, 3 months follow-up)
- Changes on spatial parameters of the upper extremity (Smoothness)(pre-camp, 3 months follow-up)
- Pediatric Evaluation of Disability Inventory questionnaire (PEDI)(pre-camp, two weeks post-camp, 3 months follow-up)
- Changes on spatial parameters of the gait (Kinematics assessments)(pre-camp, 3 months follow-up)
- Changes on temporal parameters of the gait (Swing time)(pre-camp, 3 months follow-up)
- Changes on temporal parameters of the gait (Acceleration)(pre-camp, 3 months follow-up)
- Quantification of physical activity(5 hours during 5 consecutive days)
- Changes on the Mean Diffusivity (Diffusion tensor imaging (DTI))(pre-camp, 3 months follow-up)
- Changes on temporal parameters of the gait (Cycle time)(pre-camp, 3 months follow-up)
- Changes on temporal parameters of the gait (Stance time)(pre-camp, 3 months follow-up)
Investigators
Yannick Bleyenheuft
Professor
Université Catholique de Louvain