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

Primary Purpose

Cerebral Palsy, Brain Diseases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality rehabilitation
Sponsored by
Slb Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Virtual Reality, Immersive Virtual Reality, Rehabilitation, Upper Limb, Upper extremity

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Motor Education (IEM) François Xavier FalalaRecruiting
  • Physical Medicine and Rehabilitation Center for Children and Adolescent La ClairièreRecruiting
  • E.P.A Helen KellerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Virtual Reality Group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
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.
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
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
Change in Range of Motion Measurement of upper extremity
Goniometric measurements of upper extremity range of motion (shoulder and elbow) will be done actively
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
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
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
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
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
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
Intrinsic Motivation Inventory (IMI)
Change on score of IMI - adapted version (12 questions)

Full Information

First Posted
April 19, 2022
Last Updated
October 25, 2022
Sponsor
Slb Pharma
Collaborators
European Regional Development Fund, La Région Basse-Normandie, Université de Caen Normandie
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1. Study Identification

Unique Protocol Identification Number
NCT05368922
Brief Title
Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy (RV-REEDUC)
Acronym
RV-REEDUC
Official Title
Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Slb Pharma
Collaborators
European Regional Development Fund, La Région Basse-Normandie, Université de Caen Normandie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Brain Diseases
Keywords
Cerebral Palsy, Virtual Reality, Immersive Virtual Reality, Rehabilitation, Upper Limb, Upper extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
No Masking
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Virtual Reality Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Virtual reality rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in visuomotor coordination measured by the "Drawing Trail item" of the manual dexterity domain on Movement Assessment Battery for Children
Description
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
Time Frame
Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Title
Change in speed and accuracy of movement measured by the " Posting coins item" of the manual dexterity domain on Movement Assessment Battery for Children
Description
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
Time Frame
Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Title
Change in bimanual coordination measured by the "Threading beads item" of the manual dexterity domain on Movement Assessment Battery for Children
Description
The test measures the time needed in seconds to threading 6 beads onto a string. A lower time means a better performance
Time Frame
Time frame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Secondary Outcome Measure Information:
Title
Change in performance measured by the "Catching Beanbag item" of the Aiming and Catching domain on Movement Assessment Battery for Children
Description
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
Time Frame
Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Title
Change in performance on the " Throwing Beanbag on to Mat item" of the Aiming and Catching domain of Movement Assessment Battery for Children
Description
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.
Time Frame
Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Title
Change in manual dexterity measured by the Box and Block Test
Description
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
Time Frame
Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Title
Change on score of Children's Hand-use Experience Questionnaire (27 questions)
Description
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
Time Frame
Pre-test (week 1), post-test (at 6 weeks) and 3 months follow-up (at 18 weeks)
Title
Change in Range of Motion Measurement of upper extremity
Description
Goniometric measurements of upper extremity range of motion (shoulder and elbow) will be done actively
Time Frame
Pre-test (week 1), post-test (at 6 weeks) and 3 months follow-up (at 18 weeks)
Title
Change in distance-to-target score measured by a visuomotor tracking task performed in virtual reality
Description
The score is measured in meters (m). A lower score means a better performance
Time Frame
Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Title
Change in target contact time score measured by a visuomotor tracking task performed in virtual reality
Description
Score ranges from 0-100 and is measured in percent. A higher score means a better performance
Time Frame
Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Title
Change in elbow joint range of motion measured by a visuomotor tracking task performed in virtual reality
Description
Range of motion is measured in degrees. An increase in range of motion means a better outcome
Time Frame
Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Title
Change in fluidity of movement score measured by a visuomotor tracking task performed in virtual reality
Description
Fluidity of movement is measured in with the jerk in m/s3. A lower score means a better outcome
Time Frame
Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Title
Change in movement time score measured by a pointing task performed in virtual reality
Description
The movement time is measured in seconds. A lower score means a better outcome
Time Frame
Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Title
Change in reaction time score measured by a pointing task performed in virtual reality
Description
The reaction time is measured in seconds. A lower score means a better outcome
Time Frame
Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
Title
Intrinsic Motivation Inventory (IMI)
Description
Change on score of IMI - adapted version (12 questions)
Time Frame
Pre-test ( week 1), post-test (at 6 weeks) and at the sixth session of virtual reality rehabilitation protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Héloïse Baillet, PhD
Phone
+33 (0)6.72.91.63.58
Email
heloise.baillet@unicaen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Simone Burin Chu, MSc
Phone
+33 (0)7.841.84.913
Email
simone.burin-chu@unicaen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Benguigui, Pr
Organizational Affiliation
University of Caen Normandy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Motor Education (IEM) François Xavier Falala
City
Hérouville Saint-Clair
State/Province
Normandy
ZIP/Postal Code
14200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Billard, M.D
Phone
+33 (0)2.31.58.32.30
Email
l.billard@normandie-generations.fr
Facility Name
Physical Medicine and Rehabilitation Center for Children and Adolescent La Clairière
City
Hérouville Saint-Clair
State/Province
Normandy
ZIP/Postal Code
14200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Billard, M.D
Phone
+33 (0)2.31.58.32.30
Email
l.billard@normandie-generations.fr
Facility Name
E.P.A Helen Keller
City
Le Havre
State/Province
Normandy
ZIP/Postal Code
France
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilinca Georgescu, M.D
Phone
+33 (0) 2. 35. 48. 30. 21
Email
i.georgescu@epahk.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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