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

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ClinicalTrials.gov Identifier: NCT02808156
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: unilateral upper limbs intensive training Other: bilateral upper limbs intensive training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy
Study Start Date : June 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Changes from Melbourne Assessment 2 (MA-2) [ Time Frame: baseline, week 4, week 8, week 24 ]
  2. Changes from Pediatric Motor Activity Log-Revised (PMAL-R) [ Time Frame: baseline, week 4, week 8, week 24 ]
  3. Changes from ABILHAND-Kids [ Time Frame: baseline, week 4, week 8, week 24 ]
  4. Changes from Test of Playfulness (ToP) [ Time Frame: week 1, week 4, week 5, week 8 ]
  5. Changes from Box and Block Test (BBT) [ Time Frame: weekly test (from baseline to week 8) ]
  6. Changes from Engagement Questionnaire (EQ) [ Time Frame: weekly test (from week 1 to week 8) ]
  7. Changes from Satisfactory Questionnaire (SQ) [ Time Frame: baseline, week 4, week 8, week 24 ]
  8. Changes from Building Tower Test (BTT) [ Time Frame: weekly test (from baseline to week 8) ]
  9. Changes from String Beads Test (SBT) [ Time Frame: weekly test (from baseline to week 8) ]
  10. Changes from Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) [ Time Frame: baseline, week 4, week 8, week 24 ]
  11. 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

  12. Changes from muscle strength [ Time Frame: baseline, week 8, week 24 ]
    Measured by Electromyography (EMG)


Secondary Outcome Measures :
  1. Changes from Pediatric Evaluation of Disability Inventory (PEDI) [ Time Frame: baseline, week 4, week 8, week 24 ]
  2. Changes from Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL) [ Time Frame: baseline, week 4, week 8, week 24 ]
  3. Changes from Parenting Stress Index-Short Form (PSI-short) [ Time Frame: baseline, week 4, week 8, week 24 ]


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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808156


Contacts
Contact: Tien-Ni Wang 886-2-33668163 tnwang@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Zhongzheng District, Taiwan, 100
Contact: Tien-Ni Wang    886-2-33668163    tnwang@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Tien-Ni Wang Department of Occupational Therapy, School of Medicine, National Taiwan University

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02808156     History of Changes
Other Study ID Numbers: 201512070RINA
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Keywords provided by National Taiwan University Hospital:
Cerebral Palsy,
Upper limb neurorehabilitation
Upper Extremity
Neurological Rehabilitation

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases