Clinical trial NCT05368922: Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy (RV-REEDUC)
Official title: Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Brain Diseases
Keywords: Cerebral Palsy
Virtual Reality
Immersive Virtual Reality
Rehabilitation
Upper Limb
Upper extremity
Lead sponsor: Slb Pharma
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
name: La Région Basse-Normandie
name: Université de Caen Normandie
First posted: 2022-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in visuomotor coordination measured by the "Drawing Trail item" of the manual dexterity domain on Movement Assessment Battery for Children
timeFrame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
measure: Change in speed and accuracy of movement measured by the " Posting coins item" of the manual dexterity domain on Movement Assessment Battery for Children
timeFrame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
measure: Change in bimanual coordination measured by the "Threading beads item" of the manual dexterity domain on Movement Assessment Battery for Children
timeFrame: Time frame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Secondary outcomes:
measure: Change in performance measured by the "Catching Beanbag item" of the Aiming and Catching domain on Movement Assessment Battery for Children
timeFrame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
measure: Change in performance on the " Throwing Beanbag on to Mat item" of the Aiming and Catching domain of Movement Assessment Battery for Children
timeFrame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
measure: Change in manual dexterity measured by the Box and Block Test
timeFrame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
measure: Change on score of Children's Hand-use Experience Questionnaire (27 questions)
timeFrame: Pre-test (week 1), post-test (at 6 weeks) and 3 months follow-up (at 18 weeks)
measure: Change in Range of Motion Measurement of upper extremity
timeFrame: Pre-test (week 1), post-test (at 6 weeks) and 3 months follow-up (at 18 weeks)
measure: Change in distance-to-target score measured by a visuomotor tracking task performed in virtual reality
timeFrame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
measure: Change in target contact time score measured by a visuomotor tracking task performed in virtual reality
timeFrame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
measure: Change in elbow joint range of motion measured by a visuomotor tracking task performed in virtual reality
timeFrame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
measure: Change in fluidity of movement score measured by a visuomotor tracking task performed in virtual reality
timeFrame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
measure: Change in movement time score measured by a pointing task performed in virtual reality
timeFrame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
measure: Change in reaction time score measured by a pointing task performed in virtual reality
timeFrame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
measure: Intrinsic Motivation Inventory (IMI)
timeFrame: Pre-test ( week 1), post-test (at 6 weeks) and at the sixth session of virtual reality rehabilitation protocol
Other outcomes:
Locations:
city: Hérouville Saint-Clair
country: France
facility: Institute of Motor Education (IEM) François Xavier Falala
state: Normandy
city: Hérouville Saint-Clair
country: France
facility: Physical Medicine and Rehabilitation Center for Children and Adolescent La Clairière
state: Normandy
city: Le Havre
country: France
facility: E.P.A Helen Keller
state: Normandy
Study officials:
affiliation: University of Caen Normandy
name: Nicolas Benguigui, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.