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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: unilateral upper limbs intensive training; Other: bilateral upper limbs intensive training

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tien-Ni Wang; Phone Number: 886-2-33668163; Email: tnwang@ntu.edu.tw

Study Locations

• Taiwan
  • Zhongzheng District
    • Taipei, Zhongzheng District, Taiwan, 100
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Tien-Ni Wang; Phone Number: 886-2-33668163; Email: tnwang@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: bilateral upper limbs intensive training; The bimanual intensive training focuses activities that required the use of both hands.	Other: bilateral upper limbs intensive training; The bimanual intensive training focuses activities that required the use of both hands.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Tien-Ni Wang, Department of Occupational Therapy, School of Medicine, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 24, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimated): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Upper Extremity; Neurological Rehabilitation; Upper limb neurorehabilitation; Cerebral Palsy,
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: 201512070RINA