Neurorehabilitation for children with cerebral palsy
Comparative Efficacy Research of Intensive and Distributed Constraint-Induced Therapy: Evidence-Based Neurorehabilitation in Children With CP
This study is testing two different therapy approaches to see which one helps children with cerebral palsy use their affected hand better and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Years to 13 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei, Zhongzheng District) |
| Trial ID | NCT03128385 on ClinicalTrials.gov |
What this trial studies
This research project investigates the effectiveness of two different constraint-induced therapy (CIT) models for improving motor and psychosocial outcomes in children with cerebral palsy (CP). Over three years, the study will compare an intensive CIT model with a distributed CIT model, focusing on children aged 5 to 13 who have hemiplegia and exhibit disuse of their affected hand. The study aims to identify predictors of treatment success and to comprehensively document outcomes based on the ICF-CY model. Participants will be recruited from various medical and educational institutions.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 13 years diagnosed with congenital hemiplegic cerebral palsy who show disuse of their affected hand.
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 significantly enhance rehabilitation strategies for children with cerebral palsy, improving their motor function and psychosocial well-being.
How similar studies have performed: Previous studies have shown positive outcomes with constraint-induced therapy in pediatric populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
The inclusion criteria of this study are: 1. aged between 5 and 13 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 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 — National Taiwan University Hospital
- Study coordinator: Tien-Ni Wang
- Email: tnwang@ntu.edu.tw
- Phone: 3366-8163
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.