Implementation of a New Interactive Interface Applying Motor Skill Learning Principles to Generate Motor, Functional and Neuroplastic Changes During High and Low Dosage Interventions in Children With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Change from baseline 6 Minutes Walking Test score at 1 week post-camp
Study Overview
Brief Summary
Study of the efficiency of a new interactive interface to apply all the therapeutic principles of motor skill learning used in high dosage intensive interventions. Investigation of its effects on motor, functional and neuroplastic changes in children after high and low dosage intensive interventions using or not the interface.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of unilateral cerebral palsy
- •MACS level I, II or III
- •GMFCS level I, II, III
Exclusion Criteria
- •unstable seizure
- •cognitive deficit that prevent understanding of simple games
- •botulinic toxin injection, surgery, or another unusual intervention in the 6 months preceding the study and for the duration of the study
Arms & Interventions
control group
high/low dosage intervention, intensive or not (motor function rehabilitation)
Intervention: Hand Arm Bimanual Intensive Therapy Including Lower Extremities (Behavioral)
control group
high/low dosage intervention, intensive or not (motor function rehabilitation)
Intervention: Conventional physical and occupational therapy (Behavioral)
interface group
high/low dosage intensive intervention using the interactive interface (motor function rehabilitation)
Intervention: Hand Arm Bimanual Intensive Therapy Including Lower Extremities (Behavioral)
Outcomes
Primary Outcomes
Change from baseline 6 Minutes Walking Test score at 1 week post-camp
Time Frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Measurement developped to assess the exercise tolerance and walking abilities by asking the patient to walk as much as possible during 6 minutes in a 30 meters long corridor
Change from baseline Assisting Hand Assessments score at 1 week post-camp
Time Frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
The Assisting Hand Assessment has been developped to measure and describe the efficacy of use of the affected hand of children with unilateral cerebral palsy bimanual activity performance. This is a standardized criterion-referenced test. It is conducted as a recorded semi-structured play session using specific objects usually used in a bimanual manner. With twenty-two test items, the child's performance is measured and obtain a sum score measure and a scaled score (percent scale).
Secondary Outcomes
- Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline Modified Cooper test at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline MHAVIE-child questionnaire score at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline Box and Blocks test score at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline ABILOCO-Kids questionnaire at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline Pediatric Evaluation of Disability Inventory score at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline Canadian Occupational Performance Measure scores at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
Investigators
Yannick Bleyenheuft
Professor
Université Catholique de Louvain