UnknownNot Applicable

Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy

Taiwan60 participantsStarted 2016-06

Plain-language 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 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.

Who can participate

Age range

3 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes from Melbourne Assessment 2 (MA-2)

Timeframe: baseline, week 4, week 8, week 24

Changes from Pediatric Motor Activity Log-Revised (PMAL-R)

Timeframe: baseline, week 4, week 8, week 24

Changes from ABILHAND-Kids

Timeframe: baseline, week 4, week 8, week 24

Changes from Test of Playfulness (ToP)

Timeframe: week 1, week 4, week 5, week 8

Changes from Box and Block Test (BBT)

Timeframe: weekly test (from baseline to week 8)

Changes from Engagement Questionnaire (EQ)

Timeframe: weekly test (from week 1 to week 8)

Changes from Satisfactory Questionnaire (SQ)

Timeframe: baseline, week 4, week 8, week 24

Trial details

NCT IDNCT02808156

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

Tien-Ni Wang

886-2-33668163 tnwang@ntu.edu.tw

View on ClinicalTrials.gov More Cerebral Palsy trials

Plain-language summary

Who can participate

Age range

3 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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

What they're measuring

Changes from Melbourne Assessment 2 (MA-2)

Timeframe: baseline, week 4, week 8, week 24

Changes from Pediatric Motor Activity Log-Revised (PMAL-R)

Timeframe: baseline, week 4, week 8, week 24

Changes from ABILHAND-Kids

Timeframe: baseline, week 4, week 8, week 24

Changes from Test of Playfulness (ToP)

Timeframe: week 1, week 4, week 5, week 8

Changes from Box and Block Test (BBT)

Timeframe: weekly test (from baseline to week 8)

Changes from Engagement Questionnaire (EQ)

Timeframe: weekly test (from week 1 to week 8)

Changes from Satisfactory Questionnaire (SQ)

Timeframe: baseline, week 4, week 8, week 24