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

NCT ID: NCT02808156

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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unilateral upper limbs intensive training

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

Group Type EXPERIMENTAL

unilateral upper limbs intensive training

Intervention Type OTHER

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

bilateral upper limbs intensive training

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

Group Type EXPERIMENTAL

bilateral upper limbs intensive training

Intervention Type OTHER

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

Interventions

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unilateral upper limbs intensive training

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

Intervention Type OTHER

bilateral upper limbs intensive training

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tien-Ni Wang

Role: PRINCIPAL_INVESTIGATOR

Department of Occupational Therapy, School of Medicine, National Taiwan University

Locations

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National Taiwan University Hospital

Taipei, Zhongzheng District, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tien-Ni Wang

Role: CONTACT

886-2-33668163

Facility Contacts

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Tien-Ni Wang

Role: primary

886-2-33668163

Other Identifiers

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201512070RINA

Identifier Type: -

Identifier Source: org_study_id

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