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Clinical Trials/NCT05368922
NCT05368922
Completed
N/A

Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy

Slb Pharma3 sites in 1 country20 target enrollmentApril 22, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Slb Pharma
Enrollment
20
Locations
3
Primary Endpoint
Change in speed and accuracy of movement measured by the " Posting coins item" of the manual dexterity domain on Movement Assessment Battery for Children
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 22, 2022
End Date
February 28, 2023
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Slb Pharma
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Intrinsic Motivation Inventory (IMI)(Pre-test ( week 1), post-test (at 6 weeks) and at the sixth session of virtual reality rehabilitation protocol)
  • Change on score of Children's Hand-use Experience Questionnaire (27 questions)(Pre-test (week 1), post-test (at 6 weeks) and 3 months follow-up (at 18 weeks))
  • Change in performance measured by the "Catching Beanbag item" of the Aiming and Catching domain on Movement Assessment Battery for Children(Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks))
  • Change in Range of Motion Measurement of upper extremity(Pre-test (week 1), post-test (at 6 weeks) and 3 months follow-up (at 18 weeks))
  • Change in target contact time score measured by a visuomotor tracking task performed in virtual reality(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(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(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(Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks))
  • Change in distance-to-target score measured by a visuomotor tracking task performed in virtual reality(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(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(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(Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks))

Study Sites (3)

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