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Evidence-Based Neurorehabilitation in Children With CP

Recruiting
5 - 13 years of age
Both
Phase N/A

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Overview

This 3-year research project aims to investigate and compare the treatment effectiveness (in terms of motor and psychosocial outcomes) and potential predictors (in terms of demographical, biological and psychosocial domains) of the intensive and distributed Childand Family-Friendly CIT protocols with an equivalent intervention period in children with CP by quasi randomized controlled study design. In addition, the selection and examination of outcome measures were based on the ICF-CY model to provide comprehensively documents.

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 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).

Eligibility

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

Study details

Cerebral Palsy

NCT03128385

National Taiwan University Hospital

21 March 2024

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