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Trial record 21 of 163 for:    Recruiting, Not yet recruiting, Available Studies | "Cerebral Palsy"

Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02808195
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:
The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb motor rehabilitation system (ULMTS) program on motor performance and functional outcomes.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Constraint-induced therapy Other: kinect-based constraint-induced therapy Not Applicable

Detailed Description:

The specific aims of this study project will be:

To compare the effectiveness of intervention groups using Kinect-based ULMTS with constraint-induced therapy on motor improvement in children with hemiplegic CP. The investigators hypothesize that motor improvement in using Kinect-based ULMTS will be comparable to constraint-induced therapy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy
Study Start Date : August 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: constraint-induced therapy
training of the more affected arm and restraint the less affected arm
Other: Constraint-induced therapy
Experimental: kinect-based constraint-induced therapy
training of the more affected arm and restraint the less affected arm by kinect-game
Other: kinect-based constraint-induced therapy



Primary Outcome Measures :
  1. Performance Change assessed by Kinematic analysis [ Time Frame: baseline, 2 months and 6 months ]
    Kinematic analysis including measuring the parameters of endpoint control, joint recruitment and inter-joint coordination, and trunk involvement.


Secondary Outcome Measures :
  1. score change of Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2) [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  2. score change of Melbourne Assessment 2 (MA2) [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  3. score change of Pediatric Motor Activity Log-Revised (PMAL-R) [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  4. score change of ABILHAND-kids [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  5. score change of Functional Independence Measures for children (WeeFIM) [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  6. score change of Pediatric evaluation of disability inventory (PEDI) [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  7. score change of Cerebral Palsy Quality of Life Questionnaire for Children (CP-QOL) [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  8. score change of Test of Visual Perceptual Skills-3rd (TVPS-3) [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  9. score change of Test of Playfulness (TOP) [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  10. score change of Engagement Questionnaire (EQ) [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  11. score change of Clint Satisfaction Questionnaire (CSQ) [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  12. score change of Parenting Stress Index-Short Form (PSI-SF) [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  13. Muscle strength [ Time Frame: baseline, 2 months and 6 months ]
    measured by electromyography

  14. score change of Building Tower Test [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  15. score change of Test of String Beads [ Time Frame: baseline, 1 months, 2 months and 6 months ]
  16. score change of Box and Block Test [ Time Frame: baseline, 1 months, 2 months and 6 months ]


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

Inclusion criteria are:

  1. 3-16 years old
  2. diagnosed with congenital hemiplegic or CP with one more affected side
  3. considerable nonuse of the affected upper limb.

Exclusion criteria are:

  1. no excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon & Smith, 1987)
  2. no severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
  3. no injections of botulinum toxin type A or operations on the upper limb 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): NCT02808195


Contacts
Contact: Hao-Ling Chen 886-2-3366-8162 hlchen@ntu.edu.tw
Contact: Hao-Ling Chen 886-2-3366-8162

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10048
Contact: Hao-Ling Chen    886-2-3366-8162    hlchen@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Hao-Ling Chen National Taiwan University

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02808195     History of Changes
Other Study ID Numbers: 201601057RINB
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
Neurological Rehabilitation
Upper Extremity

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