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

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ClinicalTrials.gov Identifier: NCT03219112
Recruitment Status : Completed
First Posted : July 17, 2017
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Ghent

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy, Spastic Other: Balance rehabilitation using X-box One & Kinect Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Training Balance Control Using Virtual Reality Games in Children With Cerebral Palsy and Typically Developing Children
Study Start Date : August 25, 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219112


Locations
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Belgium
Vakgroep REVAKI (Ghent University - Ghent University hospital)
Ghent, Belgium
Sponsors and Collaborators
University Ghent

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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03219112     History of Changes
Other Study ID Numbers: B670201525057
2015/0666 ( Other Identifier: Commission medical ethics University Hospital Ghent )
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Ghent:
balance
rehabilitation
exergaming
virtual reality
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases