Cerebral PalsyNCT02808156
Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy
A study testing unilateral upper limbs intensive training and bilateral upper limbs intensive training in people with Cerebral Palsy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This 3-year research project aims to investigate and compare the immediate and long-term treatment effectiveness as well as motor improving curve and potential predictors of the unimanual intensive training and bimanual intensive training protocols with an equivalent intervention period in children with hemiplegic CP… 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?
- unilateral upper limbs intensive training and bilateral upper limbs intensive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2016to Dec 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
The inclusion criteria of this study are:
- aged between 3 and 16 years
- diagnosed with congenital hemiplegic or children with CP with one more affected side; (3) apparently disuse phenomenon of the more affected hand at spontaneous contexts
Participants will be exclude for:
- excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon \& Smith, 1987)
- severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
- injections of botulinum toxin type A or operations on the UE within 6 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Zhongzheng District, 100
Tien-Ni Wang, 886-2-33668163, tnwang@ntu.edu.tw
About this study
This 3-year research project aims to investigate and compare the immediate and long-term treatment effectiveness as well as motor improving curve and potential predictors of the unimanual intensive training and bimanual intensive training protocols with an equivalent intervention period in children with hemiplegic CP and children with CP with apparently one side affected. In addition, based on the ICF-CY model, comprehensive outcome measures including motor functions as well as psychological functions will be included.
- Conditions
- Cerebral Palsy
- Being tested
- unilateral upper limbs intensive training, bilateral upper limbs intensive training
- Keywords
- Cerebral Palsy,, Upper limb neurorehabilitation, Upper Extremity, Neurological Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral upper limbs intensive trainingOther
The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm.
bilateral upper limbs intensive trainingOther
The bimanual intensive training focuses activities that required the use of both hands.
| Study group | Role | What they receive |
|---|---|---|
| unilateral upper limbs intensive training | Experimental | The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm. Receives: Other: unilateral upper limbs intensive training |
| bilateral upper limbs intensive training | Experimental | The bimanual intensive training focuses activities that required the use of both hands. Receives: Other: bilateral upper limbs intensive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Melbourne Assessment 2 (MA-2)
Measured: baseline, week 4, week 8, week 24
Changes from Pediatric Motor Activity Log-Revised (PMAL-R)
Measured: baseline, week 4, week 8, week 24
Changes from ABILHAND-Kids
Measured: baseline, week 4, week 8, week 24
Changes from Test of Playfulness (ToP)
Measured: week 1, week 4, week 5, week 8
Changes from Box and Block Test (BBT)
Measured: weekly test (from baseline to week 8)
Changes from Engagement Questionnaire (EQ)
Measured: weekly test (from week 1 to week 8)
Changes from Satisfactory Questionnaire (SQ)
Measured: baseline, week 4, week 8, week 24
Changes from Building Tower Test (BTT)
Measured: weekly test (from baseline to week 8)
Changes from String Beads Test (SBT)
Measured: weekly test (from baseline to week 8)
Changes from Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Measured: baseline, week 4, week 8, week 24
Performance changes assessed by Kinematics Analysis
Kinematic Analysis including parameters of endpoint control, inter-joints coordination, and trunk involvement, we will analyse children's performance changes from performing reaching tasks
Measured: baseline, week 8, week 24
Changes from muscle strength
Measured by Electromyography (EMG)
Measured: baseline, week 8, week 24
Secondary outcomes (3)
Changes from Pediatric Evaluation of Disability Inventory (PEDI)
Measured: baseline, week 4, week 8, week 24
Changes from Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)
Measured: baseline, week 4, week 8, week 24
Changes from Parenting Stress Index-Short Form (PSI-short)
Measured: baseline, week 4, week 8, week 24
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 startJun 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tien-Ni Wang, Principal investigator, Department of Occupational Therapy, School of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808156
- Sponsor's protocol ID
- 201512070RINA
- Status last verified
- Mar 2024
- First submitted
- 24 May 2016
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02808156
- Acronym / sponsor ID
- 201512070RINA
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy,, Upper limb neurorehabilitation, Upper Extremity, Neurological Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- 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.
This 3-year research project aims to investigate and compare the immediate and long-term treatment effectiveness as well as motor improving curve and potential predictors of the unimanual intensive training and bimanual intensive training protocols with an equivalent intervention period in children with hemiplegic CP and children with CP with apparently one side affected. In addition, based on the ICF-CY model, comprehensive outcome measures including motor functions as well as psychological functions will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral upper limbs intensive training | Experimental | Other: unilateral upper limbs intensive trainingThe unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm. |
| bilateral upper limbs intensive training | Experimental | Other: bilateral upper limbs intensive trainingThe bimanual intensive training focuses activities that required the use of both hands. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| unilateral upper limbs intensive trainingThe unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm. | Other | unilateral upper limbs intensive training |
| bilateral upper limbs intensive trainingThe bimanual intensive training focuses activities that required the use of both hands. | Other | bilateral upper limbs intensive training |
Primary outcome
Changes from Melbourne Assessment 2 (MA-2)
Time frame: baseline, week 4, week 8, week 24
Changes from Pediatric Motor Activity Log-Revised (PMAL-R)
Time frame: baseline, week 4, week 8, week 24
Changes from ABILHAND-Kids
Time frame: baseline, week 4, week 8, week 24
Changes from Test of Playfulness (ToP)
Time frame: week 1, week 4, week 5, week 8
Changes from Box and Block Test (BBT)
Time frame: weekly test (from baseline to week 8)
Changes from Engagement Questionnaire (EQ)
Time frame: weekly test (from week 1 to week 8)
Changes from Satisfactory Questionnaire (SQ)
Time frame: baseline, week 4, week 8, week 24
Changes from Building Tower Test (BTT)
Time frame: weekly test (from baseline to week 8)
Changes from String Beads Test (SBT)
Time frame: weekly test (from baseline to week 8)
Changes from Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Time frame: baseline, week 4, week 8, week 24
Performance changes assessed by Kinematics Analysis
Time frame: baseline, week 8, week 24
Kinematic Analysis including parameters of endpoint control, inter-joints coordination, and trunk involvement, we will analyse children's performance changes from performing reaching tasks
Changes from muscle strength
Time frame: baseline, week 8, week 24
Measured by Electromyography (EMG)
3 secondary outcomes
Changes from Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: baseline, week 4, week 8, week 24
Changes from Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)
Time frame: baseline, week 4, week 8, week 24
Changes from Parenting Stress Index-Short Form (PSI-short)
Time frame: baseline, week 4, week 8, week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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.
Tien-Ni Wang principal investigator
Department of Occupational Therapy, School of Medicine, 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 unilateral upper limbs intensive training and bilateral upper limbs intensive 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: status not confirmed, as of the sponsor's last update on 12 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tien-Ni Wang (886-2-33668163, tnwang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Melbourne Assessment 2 (MA-2) (time frame: baseline, week 4, week 8, week 24). The study lists 12 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 12 Mar 2024.