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

Not Applicable

Recruiting

• Conditions: Cerebral Palsy
• Interventions: Other: unilateral upper limbs intensive training; Other: bilateral upper limbs intensive training

• Registration Number: NCT02808156
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-24
• Study Start: 2016-06
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
unilateral upper limbs intensive training	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.
bilateral upper limbs intensive training	bilateral upper limbs intensive training	The bimanual intensive training focuses activities that required the use of both hands.

Primary Outcome Measures

Name	Time	Method
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 Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)	baseline, week 4, week 8, week 24
Changes from Test of Playfulness (ToP)	week 1, week 4, week 5, week 8
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 Melbourne Assessment 2 (MA-2)	baseline, week 4, week 8, week 24
Performance changes assessed by Kinematics Analysis	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 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 String Beads Test (SBT)	weekly test (from baseline to week 8)
Changes from muscle strength	baseline, week 8, week 24	Measured by Electromyography (EMG)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Zhongzheng District, Taiwan