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OpenTrials
Completed

NCT Number: NCT03219112

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

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vakgroep REVAKI (Ghent University - Ghent University hospital)

Ghent, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balance rehabilitation using X-box One & Kinect

Other

the virtual reality games (Kinect sports rivals) can be controlled with movements of the body that are registered through the kinect camera.

Primary outcomes

  1. Change in Pediatric Balance Scale compared to baseline

    Time frame: measured at baseline, after 40 minutes (of training), and after 8 weeks of training

    Clinical balance scale with 14 items such as standing unsupported for 30 sec.

Secondary outcomes

  1. Change in Bruininks-Oseretsky test for motor proficiency - subscale 'balance' and 'speed & agility' compared to baseline

    Time frame: measured at baseline, after 40 minutes (of training), and after 8 weeks of training

    Subscales of a clinical balance scale

  2. Change in Upper body kinematics compared to baseline

    Time frame: measured at baseline, after 40 minutes (of training), and after 8 weeks of training

    Trunk and arm movements measured using 3d movement registration

  3. Change in Posturography compared to baseline

    Time frame: measured at baseline, after 40 minutes (of training), and after 8 weeks of training

    Measurements on a moveable force-platform including the limits of stability during standing

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2017
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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