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Clinical Trials/NCT04403464
NCT04403464
Unknown
Not Applicable

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

Université Catholique de Louvain1 site in 1 country30 target enrollmentMay 26, 2020
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Université Catholique de Louvain
Enrollment
30
Locations
1
Primary Endpoint
Changes in ABILHAND-Kids Questionnaire
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 26, 2020
End Date
December 20, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yannick Bleyenheuft

Professor

Université Catholique de Louvain

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

Outcomes

Primary Outcomes

Changes in ABILHAND-Kids Questionnaire

Time Frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up

This ABILHAND-Kids Questionnaire has been developed to assess a child's unimanual and bimanual upper limb activities. It ranges from - 6 to +6 logits (higher score means better performance).

Changes in Gross Motor Function Measure (GMFM-66):

Time Frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up

The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.

Secondary Outcomes

  • Changes in 6 Minutes Walking Test (6MWT)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in Jebsen-Taylor Test(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in temporal parameters of the gait (Stance time)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in temporal parameters of the gait (Stride)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in Executive Functions(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in temporal parameters of the gait (Velocity)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in ACTIVLIM-CP Questionnaire(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in temporal parameters of the gait (Cycle time)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in spatial parameters of the upper extremity (Smoothness)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in Test of Arm Selective Control (TASC)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in Selective Control Assessment of the Lower Extremity (SCALE)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in Box and Blocks test (BBT)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in Modified Cooper test(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in ABILOCO-Kids Questionnaire(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in Canadian Occupational Performance Measure (COPM)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in spatial parameters of the upper extremity (Straightness)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in temporal parameters of the upper extremity (Kinematics assessments)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in Both Hands Assessment (BoHA)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in spatial parameters of the gait (Kinematics assessments)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in temporal parameters of the gait (Swing time)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in temporal parameters of the gait (Acceleration)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)

Study Sites (1)

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