NCT03219112

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

February 17, 2017

Last Update Submit

April 23, 2019

Conditions

Cerebral Palsy, Spastic

Keywords

balancerehabilitationexergamingvirtual reality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

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

  • Change in Upper body kinematics compared to baseline

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

  • Change in Posturography compared to baseline

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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Balance rehabilitation using X-box One & KinectOTHER

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

Intervention

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • No informed consent
  • surgery of the lower limbs that affects mobility
  • vestibular deficits, benign vertigo, ADHD or instable epilepsia
  • For typically developing children:
  • age: 8-11 years and 11 months
  • no history of neurologic, musculoskeletal or other impairments that could affect mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vakgroep REVAKI (Ghent University - Ghent University hospital)

Ghent, Belgium

Location

Related Publications (1)

  • Meyns P, Blanckaert I, Bras C, Jacobs N, Harlaar J, van de Pol L, Plasschaert F, Van Waelvelde H, Buizer AI. Exergaming improves balance in children with spastic cerebral palsy with low balance performance: results from a multicenter controlled trial. Disabil Rehabil. 2022 Oct;44(20):5990-5999. doi: 10.1080/09638288.2021.1954704. Epub 2021 Aug 9.

    PMID: 34365883DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2017

First Posted

July 17, 2017

Study Start

August 25, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

April 24, 2019

Record last verified: 2019-04

Locations

BE(1)