Cerebral Palsy, SpasticNCT03219112
Training Balance Control in Children With Cerebral Palsy Using Virtual Reality Games
A study testing Balance rehabilitation using X-box One & Kinect in people with Cerebral Palsy, Spastic, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Balance rehabilitation using X-box One & Kinect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Aug 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
- age: 8-11 years and 11 months
- no history of neurologic, musculoskeletal or other impairments that could affect mobility
Who cannot join
- 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:
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Vakgroep REVAKI (Ghent University - Ghent University hospital)
Ghent
About this study
Official title: 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.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Balance rehabilitation using X-box One & Kinect
- Keywords
- balance, rehabilitation, exergaming, virtual reality
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 15 cp children + 10 typically developing children (anticipated) Will have 8 weeks VR training Will have 1 VR training session Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pediatric Balance Scale compared to baseline
Clinical balance scale with 14 items such as standing unsupported for 30 sec.
Measured: 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
Subscales of a clinical balance scale
Measured: 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: 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: measured at baseline, after 40 minutes (of training), and after 8 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start25 Aug 2016
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219112
- Sponsor's protocol ID
- B670201525057
- Other IDs
- 2015/0666
- Status last verified
- Apr 2019
- First submitted
- 17 Feb 2017
- Last updated
- 24 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34365883
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Balance Control Using Virtual Reality Games in Children With Cerebral Palsy and Typically Developing Children
- ClinicalTrials.gov ID
- NCT03219112
- Acronym / sponsor ID
- B670201525057
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- balance, rehabilitation, exergaming, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 25 Aug 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Balance rehabilitation using X-box One & Kinect15 cp children + 10 typically developing children (anticipated) Will have 8 weeks VR training Will have 1 VR training session |
| Control | No intervention | –15 cp children (anticipated) Will not have 8 weeks of VR training Will not have 1 VR training session |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance rehabilitation using X-box One & Kinectthe virtual reality games (Kinect sports rivals) can be controlled with movements of the body that are registered through the kinect camera. | Other | Intervention |
Primary outcome
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.
3 secondary outcomes
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
Change in Upper body kinematics compared to baseline
Time frame: measured at baseline, after 40 minutes (of training), and after 8 weeks of training
Change in Posturography compared to baseline
Time frame: measured at baseline, after 40 minutes (of training), and after 8 weeks of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Derived from this study: PubMed 34365883Meyns 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance rehabilitation using X-box One & Kinect in people with Cerebral Palsy, Spastic, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pediatric Balance Scale compared to baseline (time frame: measured at baseline, after 40 minutes (of training), and after 8 weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03219112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.