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

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy, Spastic
• Intervention / Treatment: Other: Balance rehabilitation using X-box One & Kinect

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • Vakgroep REVAKI (Ghent University - Ghent University Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; 15 cp children + 10 typically developing children (anticipated) Will have 8 weeks VR training Will have 1 VR training session	Other: Balance rehabilitation using X-box One & Kinect; the virtual reality games (Kinect sports rivals) can be controlled with movements of the body that are registered through the kinect camera.
NO_INTERVENTION: Control; 15 cp children (anticipated) Will not have 8 weeks of VR training Will not have 1 VR training session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pediatric Balance Scale compared to baseline	Clinical balance scale with 14 items such as standing unsupported for 30 sec.	measured at baseline, after 40 minutes (of training), and after 8 weeks of training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bruininks-Oseretsky test for motor proficiency - subscale 'balance' and 'speed & agility' compared to baseline	Subscales of a clinical balance scale	measured at baseline, after 40 minutes (of training), and after 8 weeks of training
Change in Upper body kinematics compared to baseline	Trunk and arm movements measured using 3d movement registration	measured at baseline, after 40 minutes (of training), and after 8 weeks of training
Change in Posturography compared to baseline	Measurements on a moveable force-platform including the limits of stability during standing	measured at baseline, after 40 minutes (of training), and after 8 weeks of training

Collaborators and Investigators

• Sponsor: University Ghent

Study record dates

Study Major Dates

• Study Start: August 25, 2016
• Primary Completion (ACTUAL): October 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (ACTUAL): July 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: rehabilitation; virtual reality; balance; exergaming
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: B670201525057; 2015/0666 (OTHER: Commission medical ethics University Hospital Ghent)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No