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

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
unilateral upper limbs intensive training
bilateral upper limbs intensive training
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy,, Upper limb neurorehabilitation, Upper Extremity, Neurological Rehabilitation

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

unilateral upper limbs intensive training

bilateral upper limbs intensive training

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes from Melbourne Assessment 2 (MA-2)
Changes from Pediatric Motor Activity Log-Revised (PMAL-R)
Changes from ABILHAND-Kids
Changes from Test of Playfulness (ToP)
Changes from Box and Block Test (BBT)
Changes from Engagement Questionnaire (EQ)
Changes from Satisfactory Questionnaire (SQ)
Changes from Building Tower Test (BTT)
Changes from String Beads Test (SBT)
Changes from Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Performance changes assessed by Kinematics Analysis
Kinematic Analysis including parameters of endpoint control, inter-joints coordination, and trunk involvement, we will analyse children's performance changes from performing reaching tasks
Changes from muscle strength
Measured by Electromyography (EMG)

Secondary Outcome Measures

Changes from Pediatric Evaluation of Disability Inventory (PEDI)
Changes from Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)
Changes from Parenting Stress Index-Short Form (PSI-short)

Full Information

First Posted
May 24, 2016
Last Updated
February 16, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02808156
Brief Title
Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy
Official Title
Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy,, Upper limb neurorehabilitation, Upper Extremity, Neurological Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
unilateral upper limbs intensive training
Arm Type
Experimental
Arm Description
The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm.
Arm Title
bilateral upper limbs intensive training
Arm Type
Experimental
Arm Description
The bimanual intensive training focuses activities that required the use of both hands.
Intervention Type
Other
Intervention Name(s)
unilateral upper limbs intensive training
Intervention Description
The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm.
Intervention Type
Other
Intervention Name(s)
bilateral upper limbs intensive training
Intervention Description
The bimanual intensive training focuses activities that required the use of both hands.
Primary Outcome Measure Information:
Title
Changes from Melbourne Assessment 2 (MA-2)
Time Frame
baseline, week 4, week 8, week 24
Title
Changes from Pediatric Motor Activity Log-Revised (PMAL-R)
Time Frame
baseline, week 4, week 8, week 24
Title
Changes from ABILHAND-Kids
Time Frame
baseline, week 4, week 8, week 24
Title
Changes from Test of Playfulness (ToP)
Time Frame
week 1, week 4, week 5, week 8
Title
Changes from Box and Block Test (BBT)
Time Frame
weekly test (from baseline to week 8)
Title
Changes from Engagement Questionnaire (EQ)
Time Frame
weekly test (from week 1 to week 8)
Title
Changes from Satisfactory Questionnaire (SQ)
Time Frame
baseline, week 4, week 8, week 24
Title
Changes from Building Tower Test (BTT)
Time Frame
weekly test (from baseline to week 8)
Title
Changes from String Beads Test (SBT)
Time Frame
weekly test (from baseline to week 8)
Title
Changes from Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Time Frame
baseline, week 4, week 8, week 24
Title
Performance changes assessed by Kinematics Analysis
Description
Kinematic Analysis including parameters of endpoint control, inter-joints coordination, and trunk involvement, we will analyse children's performance changes from performing reaching tasks
Time Frame
baseline, week 8, week 24
Title
Changes from muscle strength
Description
Measured by Electromyography (EMG)
Time Frame
baseline, week 8, week 24
Secondary Outcome Measure Information:
Title
Changes from Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame
baseline, week 4, week 8, week 24
Title
Changes from Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)
Time Frame
baseline, week 4, week 8, week 24
Title
Changes from Parenting Stress Index-Short Form (PSI-short)
Time Frame
baseline, week 4, week 8, week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The inclusion criteria of this study are: aged between 3 and 16 years 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: excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon & Smith, 1987) severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation injections of botulinum toxin type A or operations on the UE within 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tien-Ni Wang
Phone
886-2-33668163
Email
tnwang@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tien-Ni Wang
Organizational Affiliation
Department of Occupational Therapy, School of Medicine, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Zhongzheng District
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tien-Ni Wang
Phone
886-2-33668163
Email
tnwang@ntu.edu.tw

12. IPD Sharing Statement

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

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