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

NCT02808156 | Recruiting

• 1 other identifier: 201512070RINA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy,; Upper limb neurorehabilitation; Upper Extremity; Neurological Rehabilitation

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (3)

• 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

Study Arms (2)

unilateral upper limbs intensive training

EXPERIMENTAL

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

bilateral upper limbs intensive training

EXPERIMENTAL

The bimanual intensive training focuses activities that required the use of both hands.

Other: bilateral upper limbs intensive training

Interventions

unilateral upper limbs intensive training OTHER

The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm.

unilateral upper limbs intensive training

bilateral upper limbs intensive training OTHER

The bimanual intensive training focuses activities that required the use of both hands.

bilateral upper limbs intensive training

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng District, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tien-Ni Wang

  Department of Occupational Therapy, School of Medicine, National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tien-Ni Wang

CONTACT

886-2-33668163; tnwang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 21, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

TW (1)