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Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy (RV-REEDUC)

S

Slb Pharma

Status

Completed

Conditions

Cerebral Palsy
Brain Diseases

Treatments

Device: Virtual reality rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT05368922
RV-Reeduc

Details and patient eligibility

About

This study aims to evaluate the effect of a virtual reality rehabilitation protocol on visuo-motor coordination and upper limb functional abilities in children with unilateral or bilateral cerebral palsy.

Full description

Cerebral palsy is the most common cause of motor disability in childhood. Motor disorders result in significant upper limb impairments involving limitations in daily activities. Functional rehabilitation of the upper limb therefore appears to be of primary importance in the management of this condition. However, conventional rehabilitation programs encounter some limitations such as the repetitiveness and the lack of attractivity of the proposed protocols and the poor transfer in activities of daily life. In this context, virtual reality appears as a promising tool to provide more attractive and playful protocols with a better control and a better progressivity in the stages of rehabilitation. However, scientific evidence in this area is still insufficient to define and validate specific and safe rehabilitation programs. The goal of this study is to evaluate the effects of a virtual reality rehabilitation protocol on the improvement of visuo-motor coordination and functional abilities in children with cerebral palsy. This study will include twenty-two children with unilateral or bilateral cerebral palsy who will be randomly divided into two groups: one group receiving three weekly virtual reality rehabilitation sessions for four weeks, in addition to their usual activities, and a control group only following its usual care in the same period (classical rehabilitation). Participants will be randomly matched for age, type of cerebral palsy, (hemiplegia, quadriplegia or monoplegia) and the Manual Ability Classification System (MACS). The effectiveness of the rehabilitation protocol will be evaluated through several tests assessing motor functions of the upper limb. Thus, the visuo-motor coordination, manual dexterity, evolution of joint amplitudes, kinematics of movements and functional use of the affected upper limb in daily tasks will be examined.

Enrollment

20 patients

Sex

All

Ages

8 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children aged 8 to 16 years old,
  • Diagnosed as spastic, dyskinetic or ataxic cerebral palsy,
  • Diagnosed as hemiplegia, quadriplegia or monoplegia of the upper limb,
  • Child without an intellectual disability or with a mild or moderate disability
  • Ability to understand the task by to follow verbal instructions,
  • Child who has agreed to participate in the study,
  • Child whose parents and/or legal guardians have given their consent for his/her participation in the study
  • Child who can voluntarily move his affected upper limb in a sufficient range of motion
  • Child who is a beneficiary of social security system

Exclusion criteria

  • Child with epilepsy
  • Diagnosed as diplegia or monoplegia of lower limb,
  • Severe or profound intellectual disability,
  • Severe attention deficit,
  • Pain on mobilizing upper limb
  • Botulinum toxin injections or surgery on the upper limb within 4 months of the experiment,
  • Health condition not allowing participation in the study protocol,
  • Pregnant participant,
  • Simultaneous participation in another clinical research

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Experimental: Virtual Reality Group
Experimental group
Description:
Children will receive a virtual reality rehabilitation protocol for their most affected upper limb for four weeks, on the basis of three sessions a week, in addition to their usual care. Virtual reality will be applied to participants for 30 minutes and will be based on two perceptual-motor tasks.
Treatment:
Device: Virtual reality rehabilitation
Control group
No Intervention group
Description:
Children who will be randomized to the control group will follow their usual care for four weeks (usual motor activity, including classical rehabilitation and sports or physical activities). The rehabilitation protocol will be proposed after the second post-test

Trial contacts and locations

3

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Central trial contact

Simone Burin Chu, MSc; Héloïse Baillet, PhD

Data sourced from clinicaltrials.gov

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