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| Name | Class |
|---|---|
| European Regional Development Fund | OTHER |
| La Région Basse-Normandie | OTHER |
| Université de Caen Normandie | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Benguigui, Pr | University of Caen Normandy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Motor Education (IEM) François Xavier Falala | Hérouville-Saint-Clair | Normandy | 14200 | France | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37499213 | Background | 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. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| 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 |
| Physical Medicine and Rehabilitation Center for Children and Adolescent La Clairière |
| Hérouville-Saint-Clair |
| Normandy |
| 14200 |
| France |
| E.P.A Helen Keller | Le Havre | Normandy | France | France |