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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02808156
• Other study ID #: 201512070RINA
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: National Taiwan University Hospital
• Contact: Tien-Ni Wang
• Phone: 886-2-33668163
• Email: tnwang[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

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.
• bilateral upper limbs intensive training
The bimanual intensive training focuses activities that required the use of both hands.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Zhongzheng District

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from Melbourne Assessment 2 (MA-2)		baseline, week 4, week 8, week 24
Primary	Changes from Pediatric Motor Activity Log-Revised (PMAL-R)		baseline, week 4, week 8, week 24
Primary	Changes from ABILHAND-Kids		baseline, week 4, week 8, week 24
Primary	Changes from Test of Playfulness (ToP)		week 1, week 4, week 5, week 8
Primary	Changes from Box and Block Test (BBT)		weekly test (from baseline to week 8)
Primary	Changes from Engagement Questionnaire (EQ)		weekly test (from week 1 to week 8)
Primary	Changes from Satisfactory Questionnaire (SQ)		baseline, week 4, week 8, week 24
Primary	Changes from Building Tower Test (BTT)		weekly test (from baseline to week 8)
Primary	Changes from String Beads Test (SBT)		weekly test (from baseline to week 8)
Primary	Changes from Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)		baseline, week 4, week 8, week 24
Primary	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
Primary	Changes from muscle strength	Measured by Electromyography (EMG)	baseline, week 8, week 24
Secondary	Changes from Pediatric Evaluation of Disability Inventory (PEDI)		baseline, week 4, week 8, week 24
Secondary	Changes from Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)		baseline, week 4, week 8, week 24
Secondary	Changes from Parenting Stress Index-Short Form (PSI-short)		baseline, week 4, week 8, week 24