Cerebral PalsyNCT04768374
Effects of Virtual Reality on Cerebral Palsy
A study testing Virtual Reality with Kinect and Conventional Occupational Therapy (COT) in people with Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Virtual reality (VR), is one of the most popular approaches to Cerebral Palsy (CP) rehabilitation and has been used in rehabilitation field for 30 years. VR is provided via a computer or a game console, and players interact with real-like objects . Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Virtual Reality with Kinect and Conventional Occupational Therapy (COT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2020to 20 Mar 2020
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- had to be 7 to 12 years-old,
- to be diagnosed with CP,
- to get 1 or 2 from Gross Motor Functioning Classification System,
- to get a score of 1 to 3 from Manual Ability Classification System,
- to score at least 23 from Mini Mental State Examination - children edition,
- to be able to follow verbal instructions, and
- to have the
Who cannot join
- having any surgical operation and/or botulinum toxin injection in last 6 months,
- having any visual and hearing diseases that may affect using VR, and
- participating in any other rehabilitation programs (such as physiotherapy, speech therapy, psychotherapy etc.),
- having ataxic and/or dyskinetic symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Virtual Reality on Cerebral Palsy; A Single-blind, Randomized Control Study: 3 Months Follow-up
Virtual reality (VR), is one of the most popular approaches to Cerebral Palsy (CP) rehabilitation and has been used in rehabilitation field for 30 years. VR is provided via a computer or a game console, and players interact with real-like objects . Using a VR interface as a rehabilitation tool increases the fun received by the client which, in turn, increases the participation of the client to the rehabilitation sessions.
This is a study that focused on long-term effects of Virtual reality (VR) intervention on motor skills and activities of daily living (ADL) independence of children with CP.
- Conditions
- Cerebral Palsy
- Being tested
- Virtual Reality with Kinect, Conventional Occupational Therapy (COT)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality with KinectOther
In the study it was conducted a 12 week-intensive VR intervention (twice a week, 45 minutes each) and compared the results in the 12th week to investigate the effects of rehabilitation and follow-up assessments were made in the 16th and 24th weeks. From the beginning of the VR intervention, each game was played in equal durations by each participant. However, the difficulty of the games varied depending on the child's performance.
Microsoft Kinect Games-Carnival Games was used as VR intervention. In meeting held with the authors to determine which games would be used in the VR program, 5 games were chosen and the remaining games were removed from the program because of their similar contents.
Conventional Occupational Therapy (COT)Other
The COT based on neurodevelopmental treatment was carried out by the same occupational therapist. The treatment goals aimed at increasing the use of participant's extremities and improving the independence in ADL. The activities in the treatment were chosen in view of children's motor skills and daily living activities such as getting dressed, solving puzzles, and writing etc.
Both groups received COT while the control group received COT only for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | Enrolled into 12 week VR intervention with Microsoft Kinect (twice a week, for 45 minutes) and conventional occupational therapy. Receives: Other: Virtual Reality with Kinect; Other: Conventional Occupational Therapy (COT) |
| Control group | Active comparator | Control group only received conventional occupational therapy for 12 weeks Receives: Other: Conventional Occupational Therapy (COT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Independence in Activities of Daily living (assessed with Abilhand-kids)
ABILHAND-Kids is a scale that was developed to evaluate activities of daily living (ADL) requiring upper limb usage of children aged between 6-15 years
Measured: Baseline, 12th week (end of intervention), 24th and 36th week(follow up)
Change in motor proficiency( assessed with Bruninsk-Oseretsky Test of Motor Proficiency 2-Brief Form (BOT2-BF))
BOT2-BF is a test that evaluates motor proficiency and allows therapists to compare results with specified norm values
Measured: Baseline, 12th week (end of intervention), 24th and 36th week(follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start5 Jan 2020
- Primary completion15 Mar 2020
- Study completion20 Mar 2020
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.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Uskudar University
- Responsible party
- Principal investigator, Orkun Tahir Aran, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768374
- Sponsor's protocol ID
- 61351342/ 2020- 214
- Status last verified
- Feb 2021
- First submitted
- 20 Feb 2021
- Last updated
- 24 Feb 2021
- 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 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality on Cerebral Palsy; A Single-blind, Randomized Control Study: 3 Months Follow-up
- ClinicalTrials.gov ID
- NCT04768374
- Acronym / sponsor ID
- 61351342/ 2020- 214
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Uskudar University
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 24 Feb 2021 (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.
Virtual reality (VR), is one of the most popular approaches to Cerebral Palsy (CP) rehabilitation and has been used in rehabilitation field for 30 years. VR is provided via a computer or a game console, and players interact with real-like objects . Using a VR interface as a rehabilitation tool increases the fun received by the client which, in turn, increases the participation of the client to the rehabilitation sessions.
This is a study that focused on long-term effects of Virtual reality (VR) intervention on motor skills and activities of daily living (ADL) independence of children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Other: Virtual Reality with Kinect, Other: Conventional Occupational Therapy (COT)Enrolled into 12 week VR intervention with Microsoft Kinect (twice a week, for 45 minutes) and conventional occupational therapy. |
| Control group | Active comparator | Other: Conventional Occupational Therapy (COT)Control group only received conventional occupational therapy for 12 weeks |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- had to be 7 to 12 years-old,
- to be diagnosed with CP,
- to get 1 or 2 from Gross Motor Functioning Classification System,
- to get a score of 1 to 3 from Manual Ability Classification System,
- to score at least 23 from Mini Mental State Examination - children edition,
Key exclusion criteria (4 listed)
- having any surgical operation and/or botulinum toxin injection in last 6 months,
- having any visual and hearing diseases that may affect using VR, and
- participating in any other rehabilitation programs (such as physiotherapy, speech therapy, psychotherapy etc.),
- having ataxic and/or dyskinetic symptoms.
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 |
|---|---|---|
| Virtual Reality with KinectIn the study it was conducted a 12 week-intensive VR intervention (twice a week, 45 minutes each) and compared the results in the 12th week to investigate the effects of rehabilitation and follow-up assessments were made in the 16th and 24th weeks. From the beginning of the VR intervention, each game was played in equal durations by each participant. However, the difficulty of the games varied depending on the child's performance. Microsoft Kinect Games-Carnival Games was used as VR intervention. In meeting held with the authors to determine which games would be used in the VR program, 5 games were chosen and the remaining games were removed from the program because of their similar contents. | Other | VR group |
| Conventional Occupational Therapy (COT)The COT based on neurodevelopmental treatment was carried out by the same occupational therapist. The treatment goals aimed at increasing the use of participant's extremities and improving the independence in ADL. The activities in the treatment were chosen in view of children's motor skills and daily living activities such as getting dressed, solving puzzles, and writing etc. Both groups received COT while the control group received COT only for 12 weeks. | Other | Control group, VR group |
Primary outcome
Change in Independence in Activities of Daily living (assessed with Abilhand-kids)
Time frame: Baseline, 12th week (end of intervention), 24th and 36th week(follow up)
ABILHAND-Kids is a scale that was developed to evaluate activities of daily living (ADL) requiring upper limb usage of children aged between 6-15 years
Change in motor proficiency( assessed with Bruninsk-Oseretsky Test of Motor Proficiency 2-Brief Form (BOT2-BF))
Time frame: Baseline, 12th week (end of intervention), 24th and 36th week(follow up)
BOT2-BF is a test that evaluates motor proficiency and allows therapists to compare results with specified norm values
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 Feb 2021.
- 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.
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 Virtual Reality with Kinect and Conventional Occupational Therapy (COT) in people with Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 7 inclusion and 4 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 Feb 2021. 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 Turkey (Türkiye). 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 Independence in Activities of Daily living (assessed with Abilhand-kids) (time frame: Baseline, 12th week (end of intervention), 24th and 36th week(follow up)). 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 24 Feb 2021.