Clinical trial NCT04020354: Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: motor skill learning
functional changes
neuroplastic changes
biomechanical changes
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: University Hospital, Brest
name: University of Pisa
name: University Hospital, Angers
name: University of Lausanne Hospitals
name: University of the Balearic Islands
name: Fondation Paralysie Cérébrale
First posted: 2019-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Change on Gross Motor Function (GMFM-66)
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up.
measure: Change on Manual Ability (Assisting Hand Assessment (AHA))
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up
Secondary outcomes:
measure: Melbourne 2 Assessment (MA2)
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up
measure: Inhibitory control task
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up
measure: Working memory task
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up
measure: Visuo-spatial attention assessment
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up
measure: Semmes-Weinstein monofilaments
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up
measure: Pressure Threshold
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up
measure: Activlim-CP questionnaire
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up
measure: Pediatric Evaluation of Disability Inventory questionnaire (PEDI)
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up
measure: Young children's participation and environment measure (YC-PEM)
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up
measure: Measure of Processes of Care (MPOC-20)
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: pre-camp, two weeks post-camp, 3 months follow-up
measure: 3D T1-weighted structural imaging (T1)
timeFrame: pre-camp, 3 months follow-up
measure: Changes on the Fractional Anisotropy (Diffusion tensor imaging (DTI))
timeFrame: pre-camp, 3 months follow-up
measure: Changes on the Mean Diffusivity (Diffusion tensor imaging (DTI))
timeFrame: pre-camp, 3 months follow-up
measure: Changes on resting state functional connectivity (RS)
timeFrame: pre-camp, 3 months follow-up
measure: Changes on spatial parameters of the gait (Kinematics assessments)
timeFrame: pre-camp, 3 months follow-up
measure: Changes on temporal parameters of the gait (Cycle time)
timeFrame: pre-camp, 3 months follow-up
measure: Changes on temporal parameters of the gait (Stance time)
timeFrame: pre-camp, 3 months follow-up
measure: Changes on temporal parameters of the gait (Swing time)
timeFrame: pre-camp, 3 months follow-up
measure: Changes on temporal parameters of the gait (Stride)
timeFrame: pre-camp, 3 months follow-up
measure: Changes on temporal parameters of the gait (Velocity)
timeFrame: pre-camp, 3 months follow-up
measure: Changes on temporal parameters of the gait (Acceleration)
timeFrame: pre-camp, 3 months follow-up
measure: Changes on spatial parameters of the upper extremity (Straightness)
timeFrame: pre-camp, 3 months follow-up
measure: Changes on spatial parameters of the upper extremity (Smoothness)
timeFrame: pre-camp, 3 months follow-up
measure: Changes on temporal parameters of the upper extremity (Kinematics assessments)
timeFrame: pre-camp, 3 months follow-up
measure: Quantification of physical activity
timeFrame: 5 hours during 5 consecutive days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institute of Neuroscience, Université catholique de Louvain
city: Brest
country: France
facility: Fondation ILDYS - Site de Ty Yann
city: Marina Di Pisa-Tirrenia-Calambrone
country: Italy
facility: IRCCS Fondazione Stella Maris
state: Toscana
Study officials:
affiliation: MSL-IN Lab, Institute of Neuroscience, Université catholique de Louvain
name: Yannick Bleyenheuft, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y; Early HABIT-ILE group. Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial. BMC Neurol. 2020 Apr 14;20(1):133. doi: 10.1186/s12883-020-01705-4.