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Training Balance Control in Children With Cerebral Palsy Using Virtual Reality Games

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Balance rehabilitation using X-box One & Kinect
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring balance, rehabilitation, exergaming, virtual reality

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. children diagnosed with cerebral palsy (spastic type)
  2. age: 8-11 years and 11 months
  3. bilateral CP (diplegia) & unilateral CP (hemiplegia)
  4. GMFCS level 1 & 2
  5. able to independently stand still for 2 minutes
  6. sufficient cooperation to participate in the measurements and training

Exclusion Criteria:

  1. No informed consent
  2. surgery of the lower limbs that affects mobility
  3. Botulinum-toxin A treatment within 6 months prior to inclusion in the study
  4. vestibular deficits, benign vertigo, ADHD or instable epilepsia

For typically developing children:

Inclusion criteria;

  1. age: 8-11 years and 11 months
  2. no history of neurologic, musculoskeletal or other impairments that could affect mobility

Sites / Locations

  • Vakgroep REVAKI (Ghent University - Ghent University hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

15 cp children + 10 typically developing children (anticipated) Will have 8 weeks VR training Will have 1 VR training session

15 cp children (anticipated) Will not have 8 weeks of VR training Will not have 1 VR training session

Outcomes

Primary Outcome Measures

Change in Pediatric Balance Scale compared to baseline
Clinical balance scale with 14 items such as standing unsupported for 30 sec.

Secondary Outcome Measures

Change in Bruininks-Oseretsky test for motor proficiency - subscale 'balance' and 'speed & agility' compared to baseline
Subscales of a clinical balance scale
Change in Upper body kinematics compared to baseline
Trunk and arm movements measured using 3d movement registration
Change in Posturography compared to baseline
Measurements on a moveable force-platform including the limits of stability during standing

Full Information

First Posted
February 17, 2017
Last Updated
April 23, 2019
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03219112
Brief Title
Training Balance Control in Children With Cerebral Palsy Using Virtual Reality Games
Official Title
Training Balance Control Using Virtual Reality Games in Children With Cerebral Palsy and Typically Developing Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 25, 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

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

5. Study Description

Brief Summary
In this study the clinical relevance of the use of commercially available virtual reality games in the rehabilitation of balance will be assessed in children with cerebral palsy. It will be investigated how different commercially available platforms (i.e. Xbox One + Kinect and Nintendo Wii + balance board) will affect the compensations of children with cerebral palsy to preserve their balance. The effect of 1 training session will be assessed as well as the effect of a long-term training of 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
balance, rehabilitation, exergaming, virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
15 cp children + 10 typically developing children (anticipated) Will have 8 weeks VR training Will have 1 VR training session
Arm Title
Control
Arm Type
No Intervention
Arm Description
15 cp children (anticipated) Will not have 8 weeks of VR training Will not have 1 VR training session
Intervention Type
Other
Intervention Name(s)
Balance rehabilitation using X-box One & Kinect
Intervention Description
the virtual reality games (Kinect sports rivals) can be controlled with movements of the body that are registered through the kinect camera.
Primary Outcome Measure Information:
Title
Change in Pediatric Balance Scale compared to baseline
Description
Clinical balance scale with 14 items such as standing unsupported for 30 sec.
Time Frame
measured at baseline, after 40 minutes (of training), and after 8 weeks of training
Secondary Outcome Measure Information:
Title
Change in Bruininks-Oseretsky test for motor proficiency - subscale 'balance' and 'speed & agility' compared to baseline
Description
Subscales of a clinical balance scale
Time Frame
measured at baseline, after 40 minutes (of training), and after 8 weeks of training
Title
Change in Upper body kinematics compared to baseline
Description
Trunk and arm movements measured using 3d movement registration
Time Frame
measured at baseline, after 40 minutes (of training), and after 8 weeks of training
Title
Change in Posturography compared to baseline
Description
Measurements on a moveable force-platform including the limits of stability during standing
Time Frame
measured at baseline, after 40 minutes (of training), and after 8 weeks of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children diagnosed with cerebral palsy (spastic type) age: 8-11 years and 11 months bilateral CP (diplegia) & unilateral CP (hemiplegia) GMFCS level 1 & 2 able to independently stand still for 2 minutes sufficient cooperation to participate in the measurements and training Exclusion Criteria: No informed consent surgery of the lower limbs that affects mobility Botulinum-toxin A treatment within 6 months prior to inclusion in the study vestibular deficits, benign vertigo, ADHD or instable epilepsia For typically developing children: Inclusion criteria; age: 8-11 years and 11 months no history of neurologic, musculoskeletal or other impairments that could affect mobility
Facility Information:
Facility Name
Vakgroep REVAKI (Ghent University - Ghent University hospital)
City
Ghent
Country
Belgium

12. IPD Sharing Statement

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Training Balance Control in Children With Cerebral Palsy Using Virtual Reality Games

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