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Trial record 9 of 162 for:    Recruiting, Not yet recruiting, Available Studies | "Cerebral Palsy"

Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02801279
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
The purpose of the present study is to develop a long term cost-effectiveness (efficient protocol, playful context, and practical strategy) training program for school-age children with Cerebral Palsy. Also, evaluate efficacy of Kinect-assisted bilateral arm training program for children with Cerebral Palsy.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Conventional bilateral arm training Other: Kinect-based bilateral arm training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy
Actual Study Start Date : March 4, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kinect-based bilateral arm training
The Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game.
Other: Kinect-based bilateral arm training
The conventional bilateral arm training focuses activities that required the use of both hands.

Experimental: Conventional bilateral arm training
The conventional bilateral arm training focuses activities that required the use of both hands.
Other: Conventional bilateral arm training
The Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game.




Primary Outcome Measures :
  1. Performance change of Kinematic analysis [ Time Frame: baseline, after 8 weeks, after 6 months ]

Secondary Outcome Measures :
  1. Change of muscle strength [ Time Frame: baseline, after 8 weeks, after 6 months ]
  2. Score change of Melbourne Assessment 2 (MA-2) [ Time Frame: baseline, after 4 weeks, after 8 weeks, after 6 months ]
  3. Score change of Pediatric Motor Activity Log-Revised (PMAL-R) [ Time Frame: baseline, after 4 weeks, after 8 weeks, after 6 months ]
  4. Score change of ABILHAND-Kids [ Time Frame: baseline, after 4 weeks, after 8 weeks, after 6 months ]
  5. Score change of Test of Playfulness (ToP) [ Time Frame: baseline, after 4 weeks, after 8 weeks, after 6 months ]
  6. Score change of Box and Block Test (BBT) [ Time Frame: baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months ]
  7. Score change of Engagement Questionnaire (EQ) [ Time Frame: baseline, after 4 weeks, after 8 weeks, after 6 months ]
  8. Score change of Satisfactory Questionnaire (SQ) [ Time Frame: baseline, after 4 weeks, after 8 weeks, after 6 months ]
  9. Score change of Building Tower Test (BTT) [ Time Frame: baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months ]
  10. Score change of String Beads Test (SBT) [ Time Frame: baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months ]
  11. Score change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) [ Time Frame: baseline, after 4 weeks, after 8 weeks, after 6 months ]
  12. Score change of Pediatric Evaluation of Disability Inventory (PEDI) [ Time Frame: baseline, after 4 weeks, after 8 weeks, after 6 months ]
  13. Score change of Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL) [ Time Frame: baseline, after 4 weeks, after 8 weeks, after 6 months ]
  14. Score change of Parenting Stress Index-Short Form (PSI-short) [ Time Frame: baseline, after 4 weeks, after 8 weeks, after 6 months ]
  15. Score change of Test of Visual Perceptual Skills [ Time Frame: baseline, after 4 weeks, after 8 weeks, after 6 months ]


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

The inclusion criteria of children with CP are:

  1. diagnosed with congenital hemiplegic
  2. no excessive muscle tone (Modified Ashworth Scale ≤ 3 at any joints of the upper limb)

The exclusion criteria of children with CP are:

  1. have severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
  2. have injections of botulinum toxin type A.

The inclusion criteria of typically developing children are:

  1. absence of medical or developmental diseases which would affect physical and cognitive performances
  2. having normal corrected vision
  3. studying in regular education classroom in primary school for the 6-12 year-old children.

The exclusion criteria of typically developing children are:

(1) having score not within normal limits in BOTMP-short form


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): NCT02801279


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

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 Taiwan University, Department of Occupational Therapy

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02801279     History of Changes
Other Study ID Numbers: 201503112RIND
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
Cerebral Palsy
Occupational Therapy
Upper Limb Motor Training

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