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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy

Conditions
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Brain Diseases, Cerebral Palsy

Intervention / Treatment
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* Device: Virtual reality rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Virtual Reality Group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in performance measured by the Catching Beanbag item of the Aiming and Catching domain on Movement Assessment Battery for Children | The test measures the quantity of bags caught with both hands, thrown by the tester from a distance of 1.80m. Score ranges from 0-10 correct attempts (bags). A higher number of bags caught means a better performance | 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 | The test measures the quantity of bags throw on to mat. Score ranges from 0-10 correct attempts (bags). A higher number of bags hit means better performance. | 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 | The test measures the number of transported blocks from one compartment of a box to another of equal size, within 60 seconds. Score ranges from 0-150 blocks. A higher number of blocks means better performance | 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) | The questionnaire evaluates the experience of children in using the hand, with decreased function, in activities where usually two hands are needed. Score ranges from 0-100). A higher score means a better use of the hand in daily activities | 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 | Goniometric measurements of upper extremity range of motion (shoulder and elbow) will be done actively | Pre-test (week 1), post-test (at 6 weeks) and 3 months follow-up (at 18 weeks) | 
| Change in distance-to-target score measured by a visuomotor tracking task performed in virtual reality | The score is measured in meters (m). A lower score means a better performance | Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks) | 
| Change in target contact time score measured by a visuomotor tracking task performed in virtual reality | Score ranges from 0-100 and is measured in percent. A higher score means a better performance | Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks) | 
| Change in elbow joint range of motion measured by a visuomotor tracking task performed in virtual reality | Range of motion is measured in degrees. An increase in range of motion means a better outcome | Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks) | 
| Change in fluidity of movement score measured by a visuomotor tracking task performed in virtual reality | Fluidity of movement is measured in with the jerk in m/s3. A lower score means a better outcome | Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks) | 
| Change in movement time score measured by a pointing task performed in virtual reality | The movement time is measured in seconds. A lower score means a better outcome | Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks) | 
| Change in reaction time score measured by a pointing task performed in virtual reality | The reaction time is measured in seconds. A lower score means a better outcome | Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks) | 
| Intrinsic Motivation Inventory (IMI) | Change on score of IMI - adapted version (12 questions) | Pre-test ( week 1), post-test (at 6 weeks) and at the sixth session of virtual reality rehabilitation protocol | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Virtual Reality, Immersive Virtual Reality, Rehabilitation, Upper Limb, Upper extremity