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

Cerebral Palsy, Spastic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219112
• Other study ID #: B670201525057
• Secondary ID: 2015/0666
• Status: Completed
• Phase: N/A
• Start date: August 25, 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2019
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic

Intervention

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.

Locations

Country	Name	City	State
Belgium	Vakgroep REVAKI (Ghent University - Ghent University hospital)	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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