Comparing training methods for children with cerebral palsy
Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy
This study is testing which type of training works better for kids with hemiplegic cerebral palsy—training one side of the body or both sides—to see how it helps their movement and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 3 Years to 16 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei, Zhongzheng District) |
| Trial ID | NCT02808156 on ClinicalTrials.gov |
What this trial studies
This research project investigates the effectiveness of unilateral versus bilateral intensive training in children with hemiplegic cerebral palsy over a three-year period. It aims to compare both immediate and long-term treatment outcomes, focusing on motor function improvements and psychological factors. The study will include comprehensive outcome measures based on the ICF-CY model to assess the impact of each training protocol. Participants will be children aged 3 to 16 years with specific eligibility criteria related to their condition.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 16 years diagnosed with congenital hemiplegic cerebral palsy or those with one side more affected.
Not a fit: Patients with excessive muscle tone or severe cognitive, visual, or auditory disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation strategies for children with cerebral palsy, leading to improved motor function and quality of life.
How similar studies have performed: Previous studies have shown varying success with similar rehabilitation approaches, but this specific comparison of unilateral versus bilateral training is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
The inclusion criteria of this study are: 1. aged between 3 and 16 years 2. 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: 1. excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon \& Smith, 1987) 2. severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation 3. injections of botulinum toxin type A or operations on the UE within 6 months
Where this trial is running
Taipei, Zhongzheng District
- National Taiwan University Hospital — Taipei, Zhongzheng District, Taiwan (Recruiting)
Study contacts
- Principal investigator: Tien-Ni Wang — Department of Occupational Therapy, School of Medicine, National Taiwan University
- Study coordinator: Tien-Ni Wang
- Email: tnwang@ntu.edu.tw
- Phone: 886-2-33668163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.