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Clinical Trials/NCT02808156
NCT02808156
Recruiting
Not Applicable

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

National Taiwan University Hospital1 site in 1 country60 target enrollmentJune 2016
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
National Taiwan University Hospital
Enrollment
60
Locations
1
Primary Endpoint
Changes from Satisfactory Questionnaire (SQ)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
December 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes from Satisfactory Questionnaire (SQ)

Time Frame: baseline, week 4, week 8, week 24

Changes from Building Tower Test (BTT)

Time Frame: weekly test (from baseline to week 8)

Changes from Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)

Time Frame: baseline, week 4, week 8, week 24

Changes from Test of Playfulness (ToP)

Time Frame: week 1, week 4, week 5, week 8

Changes from Box and Block Test (BBT)

Time Frame: weekly test (from baseline to week 8)

Changes from Pediatric Motor Activity Log-Revised (PMAL-R)

Time Frame: baseline, week 4, week 8, week 24

Changes from ABILHAND-Kids

Time Frame: baseline, week 4, week 8, week 24

Changes from Melbourne Assessment 2 (MA-2)

Time Frame: baseline, week 4, week 8, week 24

Performance changes assessed by Kinematics Analysis

Time Frame: baseline, week 8, week 24

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 Engagement Questionnaire (EQ)

Time Frame: weekly test (from week 1 to week 8)

Changes from String Beads Test (SBT)

Time Frame: weekly test (from baseline to week 8)

Changes from muscle strength

Time Frame: baseline, week 8, week 24

Measured by Electromyography (EMG)

Secondary Outcomes

  • Changes from Pediatric Evaluation of Disability Inventory (PEDI)(baseline, week 4, week 8, week 24)
  • Changes from Parenting Stress Index-Short Form (PSI-short)(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)

Study Sites (1)

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