Cerebral PalsyNCT02801279
Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy
A study testing Conventional bilateral arm training and Kinect-based bilateral arm training in people with Cerebral Palsy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of the present study is to develop a long term cost-effectiveness (efficient protocol, playful context, and practical strategy) training program for school-age children with Cerebral Palsy. Also, evaluate efficacy of Kinect-assisted bilateral arm training program for children with Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Conventional bilateral arm training and Kinect-based bilateral arm training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Mar 2017to 4 Jun 2024
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
The inclusion criteria of children with CP are:
- diagnosed with congenital hemiplegic
- no excessive muscle tone (Modified Ashworth Scale ≤ 3 at any joints of the upper limb)
The exclusion criteria of children with CP are:
- have severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
- have injections of botulinum toxin type A.
The inclusion criteria of typically developing children are:
- absence of medical or developmental diseases which would affect physical and cognitive performances
- having normal corrected vision
- studying in regular education classroom in primary school for the 6-12 year-old children.
The exclusion criteria of typically developing children are:
(1) having score not within normal limits in BOTMP-short form
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the present study is to develop a long term cost-effectiveness (efficient protocol, playful context, and practical strategy) training program for school-age children with Cerebral Palsy. Also, evaluate efficacy of Kinect-assisted bilateral arm training program for children with Cerebral Palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Conventional bilateral arm training, Kinect-based bilateral arm training
- Keywords
- Cerebral Palsy, Occupational Therapy, Upper Limb Motor Training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional bilateral arm trainingOther
The Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game.
Kinect-based bilateral arm trainingOther
The conventional bilateral arm training focuses activities that required the use of both hands.
| Study group | Role | What they receive |
|---|---|---|
| Kinect-based bilateral arm training | Experimental | The Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game. Receives: Other: Kinect-based bilateral arm training |
| Conventional bilateral arm training | Experimental | The conventional bilateral arm training focuses activities that required the use of both hands. Receives: Other: Conventional bilateral arm training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance change of Kinematic analysis
Measured: baseline, after 8 weeks, after 6 months
Secondary outcomes (15)
Change of muscle strength
Measured: baseline, after 8 weeks, after 6 months
Score change of Melbourne Assessment 2 (MA-2)
Measured: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Pediatric Motor Activity Log-Revised (PMAL-R)
Measured: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of ABILHAND-Kids
Measured: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Test of Playfulness (ToP)
Measured: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Box and Block Test (BBT)
Measured: baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months
Score change of Engagement Questionnaire (EQ)
Measured: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Satisfactory Questionnaire (SQ)
Measured: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Building Tower Test (BTT)
Measured: baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months
Score change of String Beads Test (SBT)
Measured: baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months
Score change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Measured: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Pediatric Evaluation of Disability Inventory (PEDI)
Measured: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)
Measured: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Parenting Stress Index-Short Form (PSI-short)
Measured: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Test of Visual Perceptual Skills
Measured: baseline, after 4 weeks, after 8 weeks, after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start4 Mar 2017
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
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 National Taiwan University HospitalThe 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
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao-Ling Chen, Principal investigator, Taiwan University, Department of Occupational Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801279
- Sponsor's protocol ID
- 201503112RIND
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2016
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02801279
- Acronym / sponsor ID
- 201503112RIND
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Occupational Therapy, Upper Limb Motor Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 4 Mar 2017 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 15 Jun 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.
The purpose of the present study is to develop a long term cost-effectiveness (efficient protocol, playful context, and practical strategy) training program for school-age children with Cerebral Palsy. Also, evaluate efficacy of Kinect-assisted bilateral arm training program for children with Cerebral Palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinect-based bilateral arm training | Experimental | Other: Kinect-based bilateral arm trainingThe Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game. |
| Conventional bilateral arm training | Experimental | Other: Conventional bilateral arm trainingThe conventional bilateral arm training focuses activities that required the use of both hands. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| Conventional bilateral arm trainingThe Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game. | Other | Conventional bilateral arm training |
| Kinect-based bilateral arm trainingThe conventional bilateral arm training focuses activities that required the use of both hands. | Other | Kinect-based bilateral arm training |
Primary outcome
Performance change of Kinematic analysis
Time frame: baseline, after 8 weeks, after 6 months
15 secondary outcomes
Change of muscle strength
Time frame: baseline, after 8 weeks, after 6 months
Score change of Melbourne Assessment 2 (MA-2)
Time frame: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Pediatric Motor Activity Log-Revised (PMAL-R)
Time frame: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of ABILHAND-Kids
Time frame: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Test of Playfulness (ToP)
Time frame: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Box and Block Test (BBT)
Time frame: baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months
Score change of Engagement Questionnaire (EQ)
Time frame: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Satisfactory Questionnaire (SQ)
Time frame: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Building Tower Test (BTT)
Time frame: baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months
Score change of String Beads Test (SBT)
Time frame: baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months
Score change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Time frame: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)
Time frame: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Parenting Stress Index-Short Form (PSI-short)
Time frame: baseline, after 4 weeks, after 8 weeks, after 6 months
Score change of Test of Visual Perceptual Skills
Time frame: baseline, after 4 weeks, after 8 weeks, after 6 months
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 20 Sep 2024.
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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.
Hao-Ling Chen principal investigator
Taiwan University, Department of Occupational Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional bilateral arm training and Kinect-based bilateral arm training in people with Cerebral Palsy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 20 Sep 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 Taiwan. 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?
Performance change of Kinematic analysis (time frame: baseline, after 8 weeks, after 6 months). 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 20 Sep 2024.