Cerebral PalsyNCT05311358
The Engineer-Built System, Video-Game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children
A study testing The engineer-built system, video-game based Kinect sensor in people with Cerebral Palsy, run by Mahidol University at 1 site in Thailand.
Trial summary
There are 3 phases of this project. First phase is to study the satisfaction in healthy children aged 10-15 years old when they are playing our computer games. The sample size of this phase was 10. In addition, we will ask the occupational therapist to play and comment our game for further development. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- The engineer-built system, video-game based Kinect sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- 10 May 2022to 21 Jun 2022
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Normal children aged 10-15 years
- Sufficient cognitive/attention capacity
- Give the informed consent
Who cannot join
- Inability to understand the instruction and follow the task
- Has severe visual or auditory impairment
- Has limb deformities that interfere with video game playing
- Got an epilepsy or convulsive condition
- Denied to give the informed consent
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Ramathibodi Hospital Mahidol University
Bangkok, 10400
About this study
There are 3 phases of this project. First phase is to study the satisfaction in healthy children aged 10-15 years old when they are playing our computer games. The sample size of this phase was 10. In addition, we will ask the occupational therapist to play and comment our game for further development.
- Conditions
- Cerebral Palsy
- Being tested
- The engineer-built system, video-game based Kinect sensor
- Keywords
- video-game based Kinect sensor, upper extremities
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The engineer-built system, video-game based Kinect sensorDevice
There are 3 computer games using Kinect sensor to detect movement of trunk and upper extremities of the children.
| Study group | Role | What they receive |
|---|---|---|
| Normal children | Experimental | Normal children aged 10-15 years play the game and comment on the satisfaction form Receives: Device: The engineer-built system, video-game based Kinect sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfaction form
The satisfaction form will be evaluated by healthy children. The satisfaction form will ask the children to rate the games in the following subjects: the presentation of game, the contents of game, the convenience for users the feeling after playing and the further suggestion about the games. There are 5-likert-scale in the satisfaction form: totally disagree, disagree, neutral, agree and totally agree.
Measured: immediately after playing game
Secondary outcomes (1)
Satisfaction form
The satisfaction form will be evaluated by occupational therapists. The satisfaction form will ask the therapist to rate the games in the following subjects: the presentation of game, the contents of game, the convenience for users the feeling after playing and the further suggestion about the games. There are 5-likert-scale in the satisfaction form: totally disagree, disagree, neutral, agree and totally agree.
Measured: immediately after playing game
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start10 May 2022
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Not applicable
- Intervention model
- Single group
- Model description
- In the first phase, we will test our video-game based Kinect sensor in healthy children aged 10-12 years old. The healthy children and the occupational therapists have to reply the satisfaction form and comment our game for further improvement. The sample size of this phase is 10.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Warakorn Charoensuk, Apiphan Iamchaimongkol, Tulyapruek Tawonsawatruk
- Responsible party
- Principal investigator, Sivaporn Vongpipatana, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311358
- Sponsor's protocol ID
- MURA2021/768
- Status last verified
- Jun 2022
- First submitted
- 8 Mar 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will share the information on satisfaction form with the engineers who developed game for game improvement.
Publications
Arneson CL, Durkin MS, Benedict RE, Kirby RS, Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS. Prevalence of cerebral palsy: Autism and Developmental Disabilities Monitoring Network, three sites, United States, 2004. Disabil Health J. 2009 Jan;2(1):45-8. doi: 10.1016/j.dhjo.2008.08.001.
PubMed 21122742Bhasin TK, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 years--Metropolitan Atlanta Developmental Disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Summ. 2006 Jan 27;55(1):1-9.
PubMed 16437058Paneth N, Hong T, Korzeniewski S. The descriptive epidemiology of cerebral palsy. Clin Perinatol. 2006 Jun;33(2):251-67. doi: 10.1016/j.clp.2006.03.011.
PubMed 16765723Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40.
PubMed 12227618Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046.
PubMed 248196827. Samia Abdel Rahman, Abdel Rahman, Afaf A. Shaheen. Virtual Reality Use in Motor Rehabilitation of Neurological Disorders: A Systematic Review. Middle-East Journal of Scientific Research; 7 (1): 63-70.
Chen YP, Kang LJ, Chuang TY, Doong JL, Lee SJ, Tsai MW, Jeng SF, Sung WH. Use of virtual reality to improve upper-extremity control in children with cerebral palsy: a single-subject design. Phys Ther. 2007 Nov;87(11):1441-57. doi: 10.2522/ptj.20060062. Epub 2007 Sep 25.
PubMed 17895352Green D, Wilson PH. Use of virtual reality in rehabilitation of movement in children with hemiplegia--a multiple case study evaluation. Disabil Rehabil. 2012;34(7):593-604. doi: 10.3109/09638288.2011.613520. Epub 2011 Oct 6.
PubMed 21978233Pruksananonda C. Cerebral palsy. In: Prasongjean P, editor. Cerebral Palsy. Bangkok: Chulolongkorn University Printing House; 2010. p. 1-3.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Engineer-Built System, Video-Game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT05311358
- Acronym / sponsor ID
- MURA2021/768
- Conditions
- Cerebral Palsy
- Keywords
- video-game based Kinect sensor, upper extremities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Warakorn Charoensuk, Apiphan Iamchaimongkol, Tulyapruek Tawonsawatruk
- Study start
- 10 May 2022 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 5 Apr 2022 (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.
There are 3 phases of this project. First phase is to study the satisfaction in healthy children aged 10-15 years old when they are playing our computer games. The sample size of this phase was 10. In addition, we will ask the occupational therapist to play and comment our game for further development.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In the first phase, we will test our video-game based Kinect sensor in healthy children aged 10-12 years old. The healthy children and the occupational therapists have to reply the satisfaction form and comment our game for further improvement. The sample size of this phase is 10.
| Arm | Type | Receives |
|---|---|---|
| Normal children | Experimental | Device: The engineer-built system, video-game based Kinect sensorNormal children aged 10-15 years play the game and comment on the satisfaction form |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Normal children aged 10-15 years
- Sufficient cognitive/attention capacity
- Give the informed consent
Key exclusion criteria (5 listed)
- Inability to understand the instruction and follow the task
- Has severe visual or auditory impairment
- Has limb deformities that interfere with video game playing
- Got an epilepsy or convulsive condition
- Denied to give the informed consent
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 |
|---|---|---|
| The engineer-built system, video-game based Kinect sensorThere are 3 computer games using Kinect sensor to detect movement of trunk and upper extremities of the children. | Device | Normal children |
Primary outcome
satisfaction form
Time frame: immediately after playing game
The satisfaction form will be evaluated by healthy children. The satisfaction form will ask the children to rate the games in the following subjects: the presentation of game, the contents of game, the convenience for users the feeling after playing and the further suggestion about the games. There are 5-likert-scale in the satisfaction form: totally disagree, disagree, neutral, agree and totally agree.
1 secondary outcome
Satisfaction form
Time frame: immediately after playing game
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 Jun 2022.
- Background: PubMed 21122742Arneson CL, Durkin MS, Benedict RE, Kirby RS, Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS. Prevalence of cerebral palsy: Autism and Developmental Disabilities Monitoring Network, three sites, United States, 2004. Disabil Health J. 2009 Jan;2(1):45-8. doi: 10.1016/j.dhjo.2008.08.001.
- Background: PubMed 16437058Bhasin TK, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 years--Metropolitan Atlanta Developmental Disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Summ. 2006 Jan 27;55(1):1-9.
- Background: PubMed 16765723Paneth N, Hong T, Korzeniewski S. The descriptive epidemiology of cerebral palsy. Clin Perinatol. 2006 Jun;33(2):251-67. doi: 10.1016/j.clp.2006.03.011.
- Background: PubMed 12227618Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40.
- Background: PubMed 24819682Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046.
- Background7. Samia Abdel Rahman, Abdel Rahman, Afaf A. Shaheen. Virtual Reality Use in Motor Rehabilitation of Neurological Disorders: A Systematic Review. Middle-East Journal of Scientific Research; 7 (1): 63-70.
- Background: PubMed 17895352Chen YP, Kang LJ, Chuang TY, Doong JL, Lee SJ, Tsai MW, Jeng SF, Sung WH. Use of virtual reality to improve upper-extremity control in children with cerebral palsy: a single-subject design. Phys Ther. 2007 Nov;87(11):1441-57. doi: 10.2522/ptj.20060062. Epub 2007 Sep 25.
- Background: PubMed 21978233Green D, Wilson PH. Use of virtual reality in rehabilitation of movement in children with hemiplegia--a multiple case study evaluation. Disabil Rehabil. 2012;34(7):593-604. doi: 10.3109/09638288.2011.613520. Epub 2011 Oct 6.
- BackgroundPruksananonda C. Cerebral palsy. In: Prasongjean P, editor. Cerebral Palsy. Bangkok: Chulolongkorn University Printing House; 2010. p. 1-3.
- Individual participant dataSharing planned: Yes. I will share the information on satisfaction form with the engineers who developed game for game improvement.
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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 The engineer-built system, video-game based Kinect sensor in people with Cerebral Palsy, run by Mahidol University at 1 site in Thailand.
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 3 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 Jun 2022. 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 Thailand. 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?
satisfaction form (time frame: immediately after playing game). 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 NCT05311358, which also lists 9 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 24 Jun 2022.