Cerebral PalsyNCT02938754
Rehabilitation Gaming System for Cerebral Palsy
A study testing VR-based motor training and Conventional Therapy in people with Cerebral Palsy and Movement Disorder, run by Universitat Pompeu Fabra at 1 site in Spain.
Trial summary
In this study the investigators evaluate the effectivity of Virtual Reality-based rehabilitation protocols for preventing motor deterioration in patients with cerebral palsy. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Cerebral Palsy, Movement Disorder
- What is being tested?
- VR-based motor training and Conventional Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2016to May 2018
- 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 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and Adult patients between 12- 50 years old diagnosed with CP according to Gross Motor Function Classification System (GMFCS). Level of disability between I and IV.
- Ashworth modified clinical scale < 3 (Ashworth, 1964, Bohannon Bohannon and Smith, 1987).
Who cannot join
- Severe visual impairment.
- Severe cognitive impairment such as mental retardation which impedes the understanding of the task.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor and Cognitive Training With the Rehabilitation Gaming System for Patients Affected by Cerebral Palsy
In this study the investigators evaluate the effectivity of Virtual Reality-based rehabilitation protocols for preventing motor deterioration in patients with cerebral palsy.
- Conditions
- Cerebral Palsy, Movement Disorder
- Being tested
- VR-based motor training, Conventional Therapy
- Keywords
- Hemiparesis, Functional independence, Virtual Rehabilitation
- Medical subject headings
- Cerebral Palsy, Movement Disorders, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based motor trainingBehavioural
Subjects will perform 3 different training protocols in Virtual Reality that imply performing tasks of vertical and planar reaching and hitting spheres, or hockey pucks, spaced at different time, speed and color.
Conventional TherapyBehavioural
Subjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements.
| Study group | Role | What they receive |
|---|---|---|
| VR-based motor training | Experimental | Subjects will perform 3 different training protocols in Virtual Reality that imply performing tasks of vertical and planar reaching and hitting spheres, or hockey pucks, spaced at different time, speed and color. Receives: Behavioral: VR-based motor training |
| Conventional Therapy | Active comparator | Subjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements. Receives: Behavioral: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor function of the affected extremity as measured by MACS clinical scale
Measured: Change from Baseline to week 5 (End of Treatment)
Secondary outcomes (3)
Change in attention and visuo-perceptive and visuo-constructional apraxia as measured by the WAIS-III scale
Measured: Change from Baseline to week 5 (End of Treatment)
Change in motor function of the affected extremity as measured by the Box and Blocks clinical scale
Measured: Change from Baseline to week 5 (End of Treatment)
Change in the amount of use of the affected arm during training as measured by the Virtual Reality system
Measured: Change from Baseline to week 5 (End of Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Pompeu Fabra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Verschure, Universitat Pompeu Fabra
- Investigators
- Paul FMJ Verschure, PhD, Principal investigator, Center of Autonomous Systems and Neurorobotics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938754
- Sponsor's protocol ID
- VR for Cerebral Palsy
- Status last verified
- Nov 2018
- First submitted
- 22 Jun 2016
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cameirao MS, Badia SB, Duarte E, Frisoli A, Verschure PF. The combined impact of virtual reality neurorehabilitation and its interfaces on upper extremity functional recovery in patients with chronic stroke. Stroke. 2012 Oct;43(10):2720-8. doi: 10.1161/STROKEAHA.112.653196. Epub 2012 Aug 7.
PubMed 22871683Wittenberg GF. Neural plasticity and treatment across the lifespan for motor deficits in cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:130-3. doi: 10.1111/j.1469-8749.2009.03425.x.
PubMed 19740220
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor and Cognitive Training With the Rehabilitation Gaming System for Patients Affected by Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02938754
- Acronym / sponsor ID
- VR for Cerebral Palsy
- Conditions
- Cerebral Palsy, Movement Disorder
- Keywords
- Hemiparesis, Functional independence, Virtual Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universitat Pompeu FabraUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 19 Oct 2016 (estimated)
- 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 investigators evaluate the effectivity of Virtual Reality-based rehabilitation protocols for preventing motor deterioration in patients with cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-based motor training | Experimental | Behavioral: VR-based motor trainingSubjects will perform 3 different training protocols in Virtual Reality that imply performing tasks of vertical and planar reaching and hitting spheres, or hockey pucks, spaced at different time, speed and color. |
| Conventional Therapy | Active comparator | Behavioral: Conventional TherapySubjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements. |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children and Adult patients between 12- 50 years old diagnosed with CP according to Gross Motor Function Classification System (GMFCS). Level of disability between I and IV.
- Ashworth modified clinical scale < 3 (Ashworth, 1964, Bohannon Bohannon and Smith, 1987).
Key exclusion criteria (2 listed)
- Severe visual impairment.
- Severe cognitive impairment such as mental retardation which impedes the understanding of the task.
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 |
|---|---|---|
| VR-based motor trainingSubjects will perform 3 different training protocols in Virtual Reality that imply performing tasks of vertical and planar reaching and hitting spheres, or hockey pucks, spaced at different time, speed and color. | Behavioural | VR-based motor training |
| Conventional TherapySubjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements. | Behavioural | Conventional Therapy |
Primary outcome
Change in motor function of the affected extremity as measured by MACS clinical scale
Time frame: Change from Baseline to week 5 (End of Treatment)
3 secondary outcomes
Change in attention and visuo-perceptive and visuo-constructional apraxia as measured by the WAIS-III scale
Time frame: Change from Baseline to week 5 (End of Treatment)
Change in motor function of the affected extremity as measured by the Box and Blocks clinical scale
Time frame: Change from Baseline to week 5 (End of Treatment)
Change in the amount of use of the affected arm during training as measured by the Virtual Reality system
Time frame: Change from Baseline to week 5 (End of Treatment)
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 5 Nov 2018.
- Background: PubMed 22871683Cameirao MS, Badia SB, Duarte E, Frisoli A, Verschure PF. The combined impact of virtual reality neurorehabilitation and its interfaces on upper extremity functional recovery in patients with chronic stroke. Stroke. 2012 Oct;43(10):2720-8. doi: 10.1161/STROKEAHA.112.653196. Epub 2012 Aug 7.
- Background: PubMed 19740220Wittenberg GF. Neural plasticity and treatment across the lifespan for motor deficits in cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:130-3. doi: 10.1111/j.1469-8749.2009.03425.x.
- Individual participant dataSharing planned: Undecided
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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.
Paul FMJ Verschure, PhD principal investigator
Center of Autonomous Systems and Neurorobotics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-based motor training and Conventional Therapy in people with Cerebral Palsy and Movement Disorder, run by Universitat Pompeu Fabra at 1 site in Spain.
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 2 inclusion and 2 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 5 Nov 2018. 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 Spain. 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 motor function of the affected extremity as measured by MACS clinical scale (time frame: Change from Baseline to week 5 (End of Treatment)). 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 NCT02938754, which also lists 2 linked publications.
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 5 Nov 2018.