Clinical trial NCT03930836: Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: motor function
motor skill learning
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 64
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Assisting Hand Assessments score at 1 week post-camp
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Change from baseline 6 Minutes Walking Test score at 1 week post-camp
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Secondary outcomes:
measure: Change from baseline Box and Blocks test score at 1 week post-camp
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Change from baseline Modified Cooper test at 1 week post-camp
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Change from baseline ABILOCO-Kids questionnaire at 1 week post-camp
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Change from baseline Pediatric Evaluation of Disability Inventory score at 1 week post-camp
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Change from baseline Canadian Occupational Performance Measure scores at 1 week post-camp
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Change from baseline MHAVIE-child questionnaire score at 1 week post-camp
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institute of Neuroscience, Université catholique de Louvain
Study officials:
References: