Cerebral PalsyNCT02808195
Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy
A study testing Constraint-induced therapy and kinect-based constraint-induced therapy in people with Cerebral Palsy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb motor rehabilitation system (ULMTS) program on motor performance and functional outcomes. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Constraint-induced therapy and kinect-based constraint-induced therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2016to 14 Mar 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3-16 years old
- diagnosed with congenital hemiplegic or CP with one more affected side
- considerable nonuse of the affected upper limb.
Who cannot join
- no excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon \& Smith, 1987)
- no severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
- no injections of botulinum toxin type A or operations on the upper limb within 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb motor rehabilitation system (ULMTS) program on motor performance and functional outcomes.
Read the detailed description
The specific aims of this study project will be:
To compare the effectiveness of intervention groups using Kinect-based ULMTS with constraint-induced therapy on motor improvement in children with hemiplegic CP. The investigators hypothesize that motor improvement in using Kinect-based ULMTS will be comparable to constraint-induced therapy.
- Conditions
- Cerebral Palsy
- Being tested
- Constraint-induced therapy, kinect-based constraint-induced therapy
- Keywords
- Cerebral Palsy, Neurological Rehabilitation, Upper Extremity
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-induced therapyOther
kinect-based constraint-induced therapyOther
| Study group | Role | What they receive |
|---|---|---|
| constraint-induced therapy | Experimental | training of the more affected arm and restraint the less affected arm Receives: Other: Constraint-induced therapy |
| kinect-based constraint-induced therapy | Experimental | training of the more affected arm and restraint the less affected arm by kinect-game Receives: Other: kinect-based constraint-induced therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Change assessed by Kinematic analysis
Kinematic analysis including measuring the parameters of endpoint control, joint recruitment and inter-joint coordination, and trunk involvement.
Measured: baseline, 2 months and 6 months
Secondary outcomes (16)
score change of Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2)
Measured: baseline, 1 months, 2 months and 6 months
score change of Melbourne Assessment 2 (MA2)
Measured: baseline, 1 months, 2 months and 6 months
score change of Pediatric Motor Activity Log-Revised (PMAL-R)
Measured: baseline, 1 months, 2 months and 6 months
score change of ABILHAND-kids
Measured: baseline, 1 months, 2 months and 6 months
score change of Functional Independence Measures for children (WeeFIM)
Measured: baseline, 1 months, 2 months and 6 months
score change of Pediatric evaluation of disability inventory (PEDI)
Measured: baseline, 1 months, 2 months and 6 months
score change of Cerebral Palsy Quality of Life Questionnaire for Children (CP-QOL)
Measured: baseline, 1 months, 2 months and 6 months
score change of Test of Visual Perceptual Skills-3rd (TVPS-3)
Measured: baseline, 1 months, 2 months and 6 months
score change of Test of Playfulness (TOP)
Measured: baseline, 1 months, 2 months and 6 months
score change of Engagement Questionnaire (EQ)
Measured: baseline, 1 months, 2 months and 6 months
score change of Clint Satisfaction Questionnaire (CSQ)
Measured: baseline, 1 months, 2 months and 6 months
score change of Parenting Stress Index-Short Form (PSI-SF)
Measured: baseline, 1 months, 2 months and 6 months
Muscle strength
measured by electromyography
Measured: baseline, 2 months and 6 months
score change of Building Tower Test
Measured: baseline, 1 months, 2 months and 6 months
score change of Test of String Beads
Measured: baseline, 1 months, 2 months and 6 months
score change of Box and Block Test
Measured: baseline, 1 months, 2 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
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.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao-Ling Chen, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808195
- Sponsor's protocol ID
- 201601057RINB
- Status last verified
- Sep 2024
- First submitted
- 24 May 2016
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Shih TY, Wang TN, Shieh JY, Lin SY, Ruan SJ, Tang HH, Chen HL. Comparative effects of kinect-based versus therapist-based constraint-induced movement therapy on motor control and daily motor function in children with unilateral cerebral palsy: a randomized control trial. J Neuroeng Rehabil. 2023 Jan 27;20(1):13. doi: 10.1186/s12984-023-01135-6.
PubMed 36703170Chen HL, Lin SY, Yeh CF, Chen RY, Tang HH, Ruan SJ, Wang TN. Development and Feasibility of a Kinect-Based Constraint-Induced Therapy Program in the Home Setting for Children With Unilateral Cerebral Palsy. Front Bioeng Biotechnol. 2021 Oct 26;9:755506. doi: 10.3389/fbioe.2021.755506. eCollection 2021.
PubMed 34765593
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
- Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02808195
- Acronym / sponsor ID
- 201601057RINB
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Neurological Rehabilitation, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 21 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 aims of the present study is to evaluate the effectiveness of Kinect-based upper limb motor rehabilitation system (ULMTS) program on motor performance and functional outcomes.
Detailed description
The specific aims of this study project will be:
To compare the effectiveness of intervention groups using Kinect-based ULMTS with constraint-induced therapy on motor improvement in children with hemiplegic CP. The investigators hypothesize that motor improvement in using Kinect-based ULMTS will be comparable to constraint-induced therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| constraint-induced therapy | Experimental | Other: Constraint-induced therapytraining of the more affected arm and restraint the less affected arm |
| kinect-based constraint-induced therapy | Experimental | Other: kinect-based constraint-induced therapytraining of the more affected arm and restraint the less affected arm by kinect-game |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 3-16 years old
- diagnosed with congenital hemiplegic or CP with one more affected side
- considerable nonuse of the affected upper limb.
Key exclusion criteria (3 listed)
- no excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon \& Smith, 1987)
- no severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
- no injections of botulinum toxin type A or operations on the upper limb within 6 months.
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 |
|---|---|---|
| Constraint-induced therapy | Other | constraint-induced therapy |
| kinect-based constraint-induced therapy | Other | kinect-based constraint-induced therapy |
Primary outcome
Performance Change assessed by Kinematic analysis
Time frame: baseline, 2 months and 6 months
Kinematic analysis including measuring the parameters of endpoint control, joint recruitment and inter-joint coordination, and trunk involvement.
16 secondary outcomes
score change of Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2)
Time frame: baseline, 1 months, 2 months and 6 months
score change of Melbourne Assessment 2 (MA2)
Time frame: baseline, 1 months, 2 months and 6 months
score change of Pediatric Motor Activity Log-Revised (PMAL-R)
Time frame: baseline, 1 months, 2 months and 6 months
score change of ABILHAND-kids
Time frame: baseline, 1 months, 2 months and 6 months
score change of Functional Independence Measures for children (WeeFIM)
Time frame: baseline, 1 months, 2 months and 6 months
score change of Pediatric evaluation of disability inventory (PEDI)
Time frame: baseline, 1 months, 2 months and 6 months
score change of Cerebral Palsy Quality of Life Questionnaire for Children (CP-QOL)
Time frame: baseline, 1 months, 2 months and 6 months
score change of Test of Visual Perceptual Skills-3rd (TVPS-3)
Time frame: baseline, 1 months, 2 months and 6 months
score change of Test of Playfulness (TOP)
Time frame: baseline, 1 months, 2 months and 6 months
score change of Engagement Questionnaire (EQ)
Time frame: baseline, 1 months, 2 months and 6 months
score change of Clint Satisfaction Questionnaire (CSQ)
Time frame: baseline, 1 months, 2 months and 6 months
score change of Parenting Stress Index-Short Form (PSI-SF)
Time frame: baseline, 1 months, 2 months and 6 months
Muscle strength
Time frame: baseline, 2 months and 6 months
score change of Building Tower Test
Time frame: baseline, 1 months, 2 months and 6 months
score change of Test of String Beads
Time frame: baseline, 1 months, 2 months and 6 months
score change of Box and Block Test
Time frame: baseline, 1 months, 2 months and 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.
- Derived from this study: PubMed 36703170Shih TY, Wang TN, Shieh JY, Lin SY, Ruan SJ, Tang HH, Chen HL. Comparative effects of kinect-based versus therapist-based constraint-induced movement therapy on motor control and daily motor function in children with unilateral cerebral palsy: a randomized control trial. J Neuroeng Rehabil. 2023 Jan 27;20(1):13. doi: 10.1186/s12984-023-01135-6.
- Derived from this study: PubMed 34765593Chen HL, Lin SY, Yeh CF, Chen RY, Tang HH, Ruan SJ, Wang TN. Development and Feasibility of a Kinect-Based Constraint-Induced Therapy Program in the Home Setting for Children With Unilateral Cerebral Palsy. Front Bioeng Biotechnol. 2021 Oct 26;9:755506. doi: 10.3389/fbioe.2021.755506. eCollection 2021.
Related trials for Cerebral Palsy
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
Active, not recruitingObservational study
Feasibility of Vision-Language Models for Detecting Physical Assistance as an Observable Criterion Defining GMFCS Levels in Children Aged 2 to 6 Years With Cerebral Palsy
Cerebral Palsy
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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
National Taiwan 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 Constraint-induced therapy and kinect-based constraint-induced therapy 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?
The sponsor lists 3 inclusion and 3 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 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 assessed by Kinematic analysis (time frame: baseline, 2 months and 6 months). 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 NCT02808195, 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 20 Sep 2024.