Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Cerebral Palsy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 5 years and 13 years
Gender
Both males and females

Description

Upper limb dysfunction is a common and disabling consequence of children with cerebral palsy (CP). As children with hemiplegia primarily have one better funcitoning side of their body and one more affected side, they often tend not to use the affected extremity resulting in the phenoema of developme...

Upper limb dysfunction is a common and disabling consequence of children with cerebral palsy (CP). As children with hemiplegia primarily have one better funcitoning side of their body and one more affected side, they often tend not to use the affected extremity resulting in the phenoema of developmental disregard. Recent evidence suggests that constraint-induced therapy (CIT) is the most effective technique to improve the use of the affected hand and reduce the developmental disregard in children with CP. However, despite the cumulative evidence supporting the effects of pediatric CIT, the concerns of feasibility and gaps of current knowledge prompt us to conduct this current proposal. The concerns of the feasibility include this approach is emotionally problematic at early stages and researchers suggested that the orginal CIT protocols may be too intrusive for children and their families. The gaps of current knowledge include: no study has directly investigated the effectiveness differences between various CIT models; no study examines, monitors and compares the psychosocial outcomes while receiving the CIT protocols for children and their parents systematically and comprehensively; and no study investigates the possible clinical characteristics of children that may influence the training effects of the various CIT models. Investigators will recruit a total of 60 children with CP from the CP Association, medical centers, and special educational systems and participants will be assigned to the two intervention groups. The intensive CIT is delivered by the group-based design with 6 hours a day for 6 days (36 hours in total) and the distributed CIT will be delivered by individualized home-based intervention with 2.25 hours a day, two times a week, for 8 weeks (36 hours in total).

Tracking Information

NCT #
NCT03128385
Collaborators
Not Provided
Investigators
Principal Investigator: Tien-Ni Wang National Taiwan University Hospital