Cerebral PalsyRV-REEDUCNCT05368922
Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy (RV-REEDUC)
A study testing Virtual reality rehabilitation in people with Cerebral Palsy and Brain Diseases, run by Slb Pharma at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Cerebral Palsy, Brain Diseases
- What is being tested?
- Virtual reality rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Apr 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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,
Show all 9Show fewer
- 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
Who cannot join
- 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,
Show all 9Show fewer
- Health condition not allowing participation in the study protocol,
- Pregnant participant,
- Simultaneous participation in another clinical research
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institute of Motor Education (IEM) François Xavier Falala
Hérouville-Saint-Clair, Normandy, 14200
Physical Medicine and Rehabilitation Center for Children and Adolescent La Clairière
Hérouville-Saint-Clair, Normandy, 14200
E.P.A Helen Keller
Le Havre, Normandy, France
About this study
Official title: Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy
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.
Read the 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.
- Conditions
- Cerebral Palsy, Brain Diseases
- Being tested
- Virtual reality rehabilitation
- Keywords
- Cerebral Palsy, Virtual Reality, Immersive Virtual Reality, Rehabilitation, Upper Limb, Upper extremity
- Medical subject headings
- Cerebral Palsy, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality rehabilitationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Pre-test ( week 1), post-test (at 6 weeks) and at the sixth session of virtual reality rehabilitation protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start22 Apr 2022
- Primary completion1 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slb Pharma
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund, La Région Basse-Normandie, Université de Caen Normandie
- Responsible party
- Sponsor
- Investigators
- Nicolas Benguigui, Pr, Principal investigator, University of Caen Normandy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368922
- Sponsor's protocol ID
- RV-Reeduc
- Acronym
- RV-REEDUC
- Status last verified
- Jun 2025
- First submitted
- 19 Apr 2022
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37499213
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05368922
- Acronym / sponsor ID
- RV-REEDUC / RV-Reeduc
- Conditions
- Cerebral Palsy, Brain Diseases
- Keywords
- Cerebral Palsy, Virtual Reality, Immersive Virtual Reality, Rehabilitation, Upper Limb, Upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Slb PharmaUniversity, hospital or other
- Collaborators
- European Regional Development Fund, La Région Basse-Normandie, Université de Caen Normandie
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Virtual Reality Group | Experimental | Device: Virtual reality rehabilitationChildren 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. |
| 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 |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (9 listed)
- Child with epilepsy
- Diagnosed as diplegia or monoplegia of lower limb,
- Severe or profound intellectual disability,
- Severe attention deficit,
- Pain on mobilizing upper limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality rehabilitationThe 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. | Device | Experimental: Virtual Reality Group |
Primary outcome
Change in visuomotor coordination measured by the "Drawing Trail item" of the manual dexterity domain on Movement Assessment Battery for Children
Time frame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
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
Change in speed and accuracy of movement measured by the " Posting coins item" of the manual dexterity domain on Movement Assessment Battery for Children
Time frame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
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
Change in bimanual coordination measured by the "Threading beads item" of the manual dexterity domain on Movement Assessment Battery for Children
Time frame: Time frame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
The test measures the time needed in seconds to threading 6 beads onto a string. A lower time means a better performance
12 secondary outcomes
Change in performance measured by the "Catching Beanbag item" of the Aiming and Catching domain on Movement Assessment Battery for Children
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Intrinsic Motivation Inventory (IMI)
Time frame: Pre-test ( week 1), post-test (at 6 weeks) and at the sixth session of virtual reality rehabilitation protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 37499213Burin-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Benguigui, Pr principal investigator
University of Caen Normandy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality rehabilitation in people with Cerebral Palsy and Brain Diseases, run by Slb Pharma at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visuomotor coordination measured by the "Drawing Trail item" of the manual dexterity domain on Movement Assessment Battery for Children (time frame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05368922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.