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Effect of a New Interactive Device on the Motor and Functional Abilities of Children With Bilateral Cerebral Palsy

U

Université Catholique de Louvain

Status

Enrolling

Conditions

Cerebral Palsy

Treatments

Behavioral: HABIT-ILE without REAtouch®
Behavioral: HABIT-ILE with REAtouch®

Study type

Interventional

Funder types

Other

Identifiers

NCT04403464
B403201316810e

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

HABIT-ILE with REAtouch®
Experimental group
Description:
Hand and Arm Bimanual Intensive Therapy Including Lower Extremities with an interactive device
Treatment:
Behavioral: HABIT-ILE with REAtouch®
HABIT-ILE without REAtouch®
Active Comparator group
Description:
Hand and Arm Bimanual Intensive Therapy Including Lower Extremities
Treatment:
Behavioral: HABIT-ILE without REAtouch®

Trial contacts and locations

1

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Central trial contact

Seyma Kilcioglu, PhD Student; Yannick Bleyenheuft, Professor

Data sourced from clinicaltrials.gov

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