Clinical trial NCT04403464: Effect of a New Interactive Device on the Motor and Functional Abilities of Children With Bilateral Cerebral Palsy
Official title: The Effect of Using a New Interactive Device Based on Motor Skill Learning Principles on the Motor and Functional Abilities of Children With Bilateral Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: motor skill learning
intensive therapy
selective voluntary motor control
cerebral palsy
assistive technology
therapeutic device
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 30
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: Recent research has shown that interventions with assistive technologies lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). REAtouch® is a new interactive interface based on motor skill learning principles. Its efficiency during intensive motor skill learning interventions has never been tested in children with bilateral cerebral palsy.

Therefore, the study aims to investigate the efficiency of using a virtual reality tool to provide a motor skill learning intervention in a randomized trial.

Detailed description: Recent research has shown that interventions with assistive technologies could lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). However they usually miss the functional motor skill learning qualities to match the changes observed in high intensity motor skill learning based interventions.REAtouch® is a new interactive interface based on motor skill learning principles that could be implemented in intensive interventions.

Therefore, the study aims to investigate the effects of intensive interventions with or without the interface on the motor and functional abilities of children with bilateral CP.

Eligibility criteria: Inclusion Criteria:

* Diagnosed bilateral cerebral palsy,
* MACS levels from I to III,
* GMFCS levels from I to III,
* Ability to follow instructions and complete testing.

Exclusion Criteria:

* Orthopedic surgery, botulinum toxin injections or another unusual intervention less than 6 months before or within the study period.
* Unstable seizure
* Severe visual or cognitive impairments likely to interfere with intervention or testing session completion

Primary outcomes:
measure: Changes in Gross Motor Function Measure (GMFM-66):
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
measure: Changes in ABILHAND-Kids Questionnaire
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Secondary outcomes:
measure: Changes in Test of Arm Selective Control (TASC)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
measure: Changes in Selective Control Assessment of the Lower Extremity (SCALE)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
measure: Changes in 6 Minutes Walking Test (6MWT)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
measure: Changes in Box and Blocks test (BBT)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
measure: Changes in Jebsen-Taylor Test
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
measure: Changes in Modified Cooper test
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
measure: Changes in ACTIVLIM-CP Questionnaire
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
measure: Changes in ABILOCO-Kids Questionnaire
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
measure: Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
measure: Changes in Canadian Occupational Performance Measure (COPM)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
measure: Changes in Both Hands Assessment (BoHA)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
measure: Changes in Executive Functions
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in spatial parameters of the gait (Kinematics assessments)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the gait (Cycle time)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the gait (Stance time)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the gait (Swing time)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the gait (Stride)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the gait (Velocity)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the gait (Acceleration)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in spatial parameters of the upper extremity (Straightness)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in spatial parameters of the upper extremity (Smoothness)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the upper extremity (Kinematics assessments)
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, UCLouvain
Study officials:
affiliation: Institute of Neuroscience, UCLouvain
name: Yannick Bleyenheuft, Professor
role: PRINCIPAL_INVESTIGATOR
References: