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Completed

NCT Number: NCT02808195

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

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.

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Key information

Conditions

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

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 10048, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

are:

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

Exclusion criteria

are:

  • no excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon & Smith, 1987)
  • no severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
  • no injections of botulinum toxin type A or operations on the upper limb within 6 months.

Treatment and study plan

Constraint-induced therapy

Other

kinect-based constraint-induced therapy

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jun 21, 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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