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

National Taiwan University

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Other: bilateral upper limbs intensive training; Other: unilateral upper limbs intensive training

Study type: Interventional

Funder types: Other

Identifiers

NCT02808156

201512070RINA

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

unilateral upper limbs intensive training

Experimental group

Description:

The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm.

Treatment:

Other: unilateral upper limbs intensive training

bilateral upper limbs intensive training

Experimental group

Description:

The bimanual intensive training focuses activities that required the use of both hands.

Treatment:

Other: bilateral upper limbs intensive training