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Completed

NCT Number: NCT02801279

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria of children with CP are:

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

The exclusion criteria of children with CP are:

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

The inclusion criteria of typically developing children are:

  • absence of medical or developmental diseases which would affect physical and cognitive performances
  • having normal corrected vision
  • 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

Treatment and study plan

Conventional bilateral arm training

Other

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

Kinect-based bilateral arm training

Other

The conventional bilateral arm training focuses activities that required the use of both hands.

Primary outcomes

  1. Performance change of Kinematic analysis

    Time frame: baseline, after 8 weeks, after 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2016
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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