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

NCT05368922 | Completed

• 1 other identifier: RV-Reeduc
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cerebral Palsy; Brain Diseases

Keywords

Cerebral Palsy; Virtual Reality; Immersive Virtual Reality; Rehabilitation; Upper Limb; Upper extremity

Outcome Measures

Primary Outcomes (3)

• Change in visuomotor coordination measured by the "Drawing Trail item" of the manual dexterity domain on Movement Assessment Battery for Children

  The test measures the number of failures (number of times the boundaries are crossed) performed when tracing a continuous line on a trail. A decrease in the number of failures means a better performance

  Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)

• Change in speed and accuracy of movement measured by the " Posting coins item" of the manual dexterity domain on Movement Assessment Battery for Children

  The test measures the time needed in seconds to posting 6 coins into a money box with the affected hand. A lower time means a better performance

  Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)

• Change in bimanual coordination measured by the "Threading beads item" of the manual dexterity domain on Movement Assessment Battery for Children

  The test measures the time needed in seconds to threading 6 beads onto a string. A lower time means a better performance

  Time frame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)

Secondary Outcomes (12)

• Change in performance measured by the "Catching Beanbag item" of the Aiming and Catching domain on Movement Assessment Battery for Children

  Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)

• Change in performance on the " Throwing Beanbag on to Mat item" of the Aiming and Catching domain of Movement Assessment Battery for Children

  Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)

• Change in manual dexterity measured by the Box and Block Test

  Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)

• Change on score of Children's Hand-use Experience Questionnaire (27 questions)

  Pre-test (week 1), post-test (at 6 weeks) and 3 months follow-up (at 18 weeks)

• Change in Range of Motion Measurement of upper extremity

  Pre-test (week 1), post-test (at 6 weeks) and 3 months follow-up (at 18 weeks)

Study Arms (2)

Experimental: Virtual Reality Group

EXPERIMENTAL

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.

Device: Virtual reality rehabilitation

Control group

NO INTERVENTION

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

Interventions

Virtual reality rehabilitation DEVICE

The virtual reality rehabilitation protocol will be based on two perceptual-motor tasks (e.g., visuomotor tracking task and pointing task) in a 3D environment. The visuomotor tracking task will consist in tracking a virtual target moving with an effector manipulated by a remote controller. The pointing task will consist in tapping targets that are in a cube as quickly as possible with an effector manipulated by a remote controller. Both tasks will be performed in a 3D virtual playful environment. The rehabilitation protocol will follow a progression through the manipulation of the virtual environment and the constraints of the tasks.

Experimental: Virtual Reality Group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Slb Pharma: lead
• European Regional Development Fund: collaborator
• La Région Basse-Normandie: collaborator
• Université de Caen Normandie: collaborator

Study Sites (3)

Institute of Motor Education (IEM) François Xavier Falala

Hérouville-Saint-Clair, Normandy, 14200, France

Location

Physical Medicine and Rehabilitation Center for Children and Adolescent La Clairière

Hérouville-Saint-Clair, Normandy, 14200, France

Location

E.P.A Helen Keller

Le Havre, Normandy, France, France

Location

Related Publications (1)

• Burin-Chu S, Baillet H, Leconte P, Lejeune L, Thouvarecq R, Benguigui N. Effectiveness of virtual reality interventions of the upper limb in children and young adults with cerebral palsy: A systematic review with meta-analysis. Clin Rehabil. 2024 Jan;38(1):15-33. doi: 10.1177/02692155231187858. Epub 2023 Jul 27.

  PMID: 37499213 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Brain Diseases

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nicolas Benguigui, Pr

  University of Caen Normandy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No Masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multi-center randomized controlled trial will be implemented across three different locations. Twenty-two children will be randomly divided into an experimental group that will follow a virtual reality rehabilitation protocol with a pre-test and two post tests and with three weekly sessions for four weeks, and a control group which will only carry out the pre and posttests.

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 10, 2022
• Study Start: April 22, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 28, 2023
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)