Cerebral PalsyNCT06478082
Home-based Virtual Reality Rehabilitation for Children With Cerebral Palsy
A study testing Home-based virtual reality training in people with Cerebral Palsy, run by Sint Maartenskliniek at 1 site in Netherlands.
Trial summary
Rationale: In a way, VR-based gaming shows some similarities to Constraint-induced movement therapy. VR games are controlled unimanually or bimanually. When unimanually-controlled games are performed with the affected upper limb, movements of the unaffected hand are completely ineffective. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Home-based virtual reality training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Apr 2021to 3 Jul 2023
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- CP children with a unilateral or severely asymmetric, bilateral spastic movement impairment.
- Age 10-18 years old.
- Manual Ability Classification System (MACS) scores I, II or III.
- House classification of 1, 2 or 3.
Who cannot join
- Significant (persisting) motion sickness, or any other related adverse event in VR.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Gaming to Improve Upper Limb Functionality in Children With Cerebral Palsy
Rationale: In a way, VR-based gaming shows some similarities to Constraint-induced movement therapy. VR games are controlled unimanually or bimanually. When unimanually-controlled games are performed with the affected upper limb, movements of the unaffected hand are completely ineffective. This mimics the principle of forced use. To some degree, also bimanually-controlled games result in a forced use of the affected upper limb.
Additionally, VR could help in the engagement in rehabilitation programs, as virtual environments and gaming increases enjoyment and motivation, and therefore therapy adherence. Accordingly, VR-based gaming may have the potential to improve upper limb functionality in children with CP.
Read more
Objective: This study aims to investigate the feasibility of a home-based VR intervention to improve upper limb functionality in children with CP. Sub-objective: The validation of a self-developed upper limb assessment (Upper Limb Reaching Test).
Study population: Children and adolescents with unilateral CP (age 10-18 years old). Intervention: The intervention consists of VR-based rehabilitation with the Oculus Quest device. The training frequency and duration represents 2x15 minutes a day, five days a week, for a total of eight weeks. Therefore, this rehabilitation intervention should represent a total amount of 20 hours of rehabilitation. However, the total dosage is variable as the intervention is self-managed.
Main study parameters/endpoints: Logbook, System Usability Scale, Melbourne Assessment 2, Wall Arm Reaching Test, Elbow and shoulder range of motion.
- Conditions
- Cerebral Palsy
- Being tested
- Home-based virtual reality training
- Keywords
- Home-based rehabilitation, Virtual Reality, Upper limb
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based virtual reality trainingDevice
8-week training with an advised frequency of 30 minutes per day, for 5 days per week.
| Study group | Role | What they receive |
|---|---|---|
| Children with unilateral Cerebral Palsy | Experimental | All children have unilateral cerebral palsy and are between 1-18 years old Receives: Device: Home-based virtual reality training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Logbook
Participants keep a logbook in which they log the date of training, games played, duration of activity and enjoyment of game
Measured: During the 8-week intervention period
System Usability Scale
This questionnaire consists of 10 items regarding the usability of the virtual reality training. Scores ranging between 0-100, with a higher score indicating better usability
Measured: After the 8-week intervention
Secondary outcomes (4)
Melbourne Assessment 2
Item 1,2,10 and 13 were measured to evaluate quality of upper limb movements, specifically reaching movements. Scores ranging between 0-33, with a higher score indicating better arm function.
Measured: Before and after 8-week intervention
Wall Arm Reaching Test
A test to evaluate the reaching ability in children with cerebral palsy. Children have to alternate with their arm between the hip and a target on the wall as fast a possible in 30 seconds. Scoring starts at 0 and has no maximum. A higher score, indicates a better arm functioning.
Measured: Before and after 8-week intervention
Range of motion Elbow
Passive and active range of motion of the extension of the elbow. Ranging between 0-180 degrees. Closer to 0 indicating better extension.
Measured: Before and after 8-week intervention
Rang om motion Shoulder
Passive and active range of motion of the anteflexion of the shoulder. Ranging between 0-180 degrees. Closer to 180 indicating better anteflexion.
Measured: Before and after 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start12 Apr 2021
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noël Keijsers, Prof., Principal investigator, Donders Institute for Brain, Cognition and Behavior, Radboud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478082
- Sponsor's protocol ID
- 885
- Status last verified
- Jun 2024
- First submitted
- 6 Mar 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Gaming to Improve Upper Limb Functionality in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06478082
- Acronym / sponsor ID
- 885
- Conditions
- Cerebral Palsy
- Keywords
- Home-based rehabilitation, Virtual Reality, Upper limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 27 Jun 2024 (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.
Rationale: In a way, VR-based gaming shows some similarities to Constraint-induced movement therapy. VR games are controlled unimanually or bimanually. When unimanually-controlled games are performed with the affected upper limb, movements of the unaffected hand are completely ineffective. This mimics the principle of forced use. To some degree, also bimanually-controlled games result in a forced use of the affected upper limb.
Additionally, VR could help in the engagement in rehabilitation programs, as virtual environments and gaming increases enjoyment and motivation, and therefore therapy adherence. Accordingly, VR-based gaming may have the potential to improve upper limb functionality in children with CP.
Objective: This study aims to investigate the feasibility of a home-based VR intervention to improve upper limb functionality in children with CP. Sub-objective: The validation of a self-developed upper limb assessment (Upper Limb Reaching Test).
Study population: Children and adolescents with unilateral CP (age 10-18 years old). Intervention: The intervention consists of VR-based rehabilitation with the Oculus Quest device. The training frequency and duration represents 2x15 minutes a day, five days a week, for a total of eight weeks. Therefore, this rehabilitation intervention should represent a total amount of 20 hours of rehabilitation. However, the total dosage is variable as the intervention is self-managed.
Main study parameters/endpoints: Logbook, System Usability Scale, Melbourne Assessment 2, Wall Arm Reaching Test, Elbow and shoulder range of motion.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with unilateral Cerebral Palsy | Experimental | Device: Home-based virtual reality trainingAll children have unilateral cerebral palsy and are between 1-18 years old |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- CP children with a unilateral or severely asymmetric, bilateral spastic movement impairment.
- Age 10-18 years old.
- Manual Ability Classification System (MACS) scores I, II or III.
- House classification of 1, 2 or 3.
Key exclusion criteria (1 listed)
- Significant (persisting) motion sickness, or any other related adverse event in VR.
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 |
|---|---|---|
| Home-based virtual reality training8-week training with an advised frequency of 30 minutes per day, for 5 days per week. | Device | Children with unilateral Cerebral Palsy |
Primary outcome
Logbook
Time frame: During the 8-week intervention period
Participants keep a logbook in which they log the date of training, games played, duration of activity and enjoyment of game
System Usability Scale
Time frame: After the 8-week intervention
This questionnaire consists of 10 items regarding the usability of the virtual reality training. Scores ranging between 0-100, with a higher score indicating better usability
4 secondary outcomes
Melbourne Assessment 2
Time frame: Before and after 8-week intervention
Wall Arm Reaching Test
Time frame: Before and after 8-week intervention
Range of motion Elbow
Time frame: Before and after 8-week intervention
Rang om motion Shoulder
Time frame: Before and after 8-week intervention
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 27 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Noël Keijsers, Prof. principal investigator
Donders Institute for Brain, Cognition and Behavior, Radboud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based virtual reality training in people with Cerebral Palsy, run by Sint Maartenskliniek at 1 site in Netherlands.
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 4 inclusion and 1 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 27 Jun 2024. 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 Netherlands. 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?
Logbook (time frame: During the 8-week intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2024.