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

Study Overview
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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.

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: unilateral upper limbs intensive training
* Other: bilateral upper limbs intensive training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: unilateral upper limbs intensive training<br>The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm. | Other: unilateral upper limbs intensive training<br>* The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm.<br>|
| Experimental: bilateral upper limbs intensive training<br>The bimanual intensive training focuses activities that required the use of both hands. | Other: bilateral upper limbs intensive training<br>* The bimanual intensive training focuses activities that required the use of both hands.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Melbourne Assessment 2 (MA-2) |  | baseline, week 4, week 8, week 24 | 
| Changes from Pediatric Motor Activity Log-Revised (PMAL-R) |  | baseline, week 4, week 8, week 24 | 
| Changes from ABILHAND-Kids |  | baseline, week 4, week 8, week 24 | 
| Changes from Test of Playfulness (ToP) |  | week 1, week 4, week 5, week 8 | 
| Changes from Box and Block Test (BBT) |  | weekly test (from baseline to week 8) | 
| Changes from Engagement Questionnaire (EQ) |  | weekly test (from week 1 to week 8) | 
| Changes from Satisfactory Questionnaire (SQ) |  | baseline, week 4, week 8, week 24 | 
| Changes from Building Tower Test (BTT) |  | weekly test (from baseline to week 8) | 
| Changes from String Beads Test (SBT) |  | weekly test (from baseline to week 8) | 
| Changes from Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) |  | baseline, week 4, week 8, week 24 | 
| 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 | baseline, week 8, week 24 | 
| Changes from muscle strength | Measured by Electromyography (EMG) | baseline, week 8, week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Pediatric Evaluation of Disability Inventory (PEDI) |  | baseline, week 4, week 8, week 24 | 
| Changes from Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL) |  | baseline, week 4, week 8, week 24 | 
| Changes from Parenting Stress Index-Short Form (PSI-short) |  | baseline, week 4, week 8, week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy,, Upper limb neurorehabilitation, Upper Extremity, Neurological Rehabilitation