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Kinect Sensor in Cerebral Palsy Children: Phase 2.1

Primary Purpose

Cerebral Palsy Children, Upper Extremity Problem

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
the engineer-built system, video-game based Kinect sensor
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy Children focused on measuring video-game, Kinect sensor, upper extremities problems, cerebral palsy, children

Eligibility Criteria

10 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Spastic cerebral palsy aged 10-15 years
  • Sufficient cognitive/attention capacity to understand basic instructions
  • Can cooperate with the therapist for short period of time during training
  • Manual Ability Classification System (MACS) 2-3
  • Zancolli classification of the affected upper extremity was grade I-II.
  • Give the informed consent

Exclusion Criteria:

  • Inability to understand the instruction and follow the task
  • Severe comorbidities, visual or auditory impairment
  • Had history of Botulinum toxin injection on the affected upper extremity for last 6 months or receive the injection during the study time
  • Other treatment options planned on the affected upper extremity during the study time
  • Wear daytime orthosis on the affected limb
  • Zancolli classification of the affected hand was grade III.
  • Got an epilepsy or convulsive condition
  • Denied to give the informed consent or continue the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    video game in CP children (pilot study)

    Arm Description

    The cerebral palsy children will play the engineer-built system, video-game based Kinect sensor 3 times/week for 5 weeks. Each session will last for 40 minutes. The video-game Kinect sensor was developed by the researcher team.

    Outcomes

    Primary Outcome Measures

    Range of Motion
    The range or motion of shoulder, elbow and wrist will be assessed by goniometer. The assessment will be done before starting the intervention as the baseline and then after finishing the intervention to detect change of range of motion from the the baseline. The range of motion will be reported in degrees.

    Secondary Outcome Measures

    Box and block test
    The name 'box and block test' is an unabbreviated scale title. The minimum score is zero and the maximum score is infinity.
    ABILHANDS-Kids
    The ABILHANDS-kids is the name of the test. It is not an unabbreviated name. The children will be asked the difficulty of doing their activities of daily living by using 21 questionnaires. The rating of difficulties were impossible, difficult and easy. Then the rating would be score as impossible=0, difficult=1 and easy = 2. The analysis of the score of there items will use the Rasch analysis which it is available online on http://rssandbox.iescagilly.be/~abilhand-kids-cerebral-palsy-en.html. The minimum score means a worse outcome and the maximum score means the better outcome.
    EQ-5D-Y
    The EQ-5D-Y is a questionnaire which has 2 parts for a participant to complete. There are 5 questions asking in first part: mobility, looking after myself, doing usual activities, having pain or discomfort and feelin worried, sad or unhappy. The participant needs to rate these questions in 3 rating score: no problem, with some problem or with a lot of problem. The rating score will be coded as no problem=1, with some problem = 1 and with a lot of problem = 2. The code 11111 is the best condition and the code 33333 is the worst condition. The second part of the questionnaire is the EQ-VAS which the participants need to rate their condition on the linear scale from 0-100. The worst condition is score 0 and the best condition is score 100.Then the coding from the first part will be converted as an index value.

    Full Information

    First Posted
    March 25, 2022
    Last Updated
    September 16, 2022
    Sponsor
    Mahidol University
    Collaborators
    Warakorn Charoensuk, Apiphan Iamchaimongkol, Tulyapruek Tawonsawatruk
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05338229
    Brief Title
    Kinect Sensor in Cerebral Palsy Children: Phase 2.1
    Official Title
    The Engineer-built System, Video-game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children: Phase 2.1
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Protocal changing due to time limitation
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mahidol University
    Collaborators
    Warakorn Charoensuk, Apiphan Iamchaimongkol, Tulyapruek Tawonsawatruk

    4. Oversight

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

    5. Study Description

    Brief Summary
    There are 3 phases of the study. This registration is phase 2.1.This registration will conduct a pilot study in the cerebral palsy children.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy Children, Upper Extremity Problem
    Keywords
    video-game, Kinect sensor, upper extremities problems, cerebral palsy, children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    video game in CP children (pilot study)
    Arm Type
    Experimental
    Arm Description
    The cerebral palsy children will play the engineer-built system, video-game based Kinect sensor 3 times/week for 5 weeks. Each session will last for 40 minutes. The video-game Kinect sensor was developed by the researcher team.
    Intervention Type
    Device
    Intervention Name(s)
    the engineer-built system, video-game based Kinect sensor
    Intervention Description
    The engineer-built system, video-game based Kinect sensor was developed by the researcher team.
    Primary Outcome Measure Information:
    Title
    Range of Motion
    Description
    The range or motion of shoulder, elbow and wrist will be assessed by goniometer. The assessment will be done before starting the intervention as the baseline and then after finishing the intervention to detect change of range of motion from the the baseline. The range of motion will be reported in degrees.
    Time Frame
    before starting the intervention and after finishing the intervention within 1 week
    Secondary Outcome Measure Information:
    Title
    Box and block test
    Description
    The name 'box and block test' is an unabbreviated scale title. The minimum score is zero and the maximum score is infinity.
    Time Frame
    before starting the intervention and after finishing the intervention within 1 week
    Title
    ABILHANDS-Kids
    Description
    The ABILHANDS-kids is the name of the test. It is not an unabbreviated name. The children will be asked the difficulty of doing their activities of daily living by using 21 questionnaires. The rating of difficulties were impossible, difficult and easy. Then the rating would be score as impossible=0, difficult=1 and easy = 2. The analysis of the score of there items will use the Rasch analysis which it is available online on http://rssandbox.iescagilly.be/~abilhand-kids-cerebral-palsy-en.html. The minimum score means a worse outcome and the maximum score means the better outcome.
    Time Frame
    before starting the intervention and after finishing the intervention within 1 week
    Title
    EQ-5D-Y
    Description
    The EQ-5D-Y is a questionnaire which has 2 parts for a participant to complete. There are 5 questions asking in first part: mobility, looking after myself, doing usual activities, having pain or discomfort and feelin worried, sad or unhappy. The participant needs to rate these questions in 3 rating score: no problem, with some problem or with a lot of problem. The rating score will be coded as no problem=1, with some problem = 1 and with a lot of problem = 2. The code 11111 is the best condition and the code 33333 is the worst condition. The second part of the questionnaire is the EQ-VAS which the participants need to rate their condition on the linear scale from 0-100. The worst condition is score 0 and the best condition is score 100.Then the coding from the first part will be converted as an index value.
    Time Frame
    before starting the intervention and after finishing the intervention within 1 week
    Other Pre-specified Outcome Measures:
    Title
    patient satisfaction form
    Description
    The patient satisfaction form is about the questionnaire asking about the satisfaction of playing game in these areas: the presentation of games: the contents of game, the convenience and the outcome after playing game. The participants will rate each question in 5-likert scale: totally disagree, disagree, neutral, agree and totally agree.
    Time Frame
    immediately after finishing the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Spastic cerebral palsy aged 10-15 years Sufficient cognitive/attention capacity to understand basic instructions Can cooperate with the therapist for short period of time during training Manual Ability Classification System (MACS) 2-3 Zancolli classification of the affected upper extremity was grade I-II. Give the informed consent Exclusion Criteria: Inability to understand the instruction and follow the task Severe comorbidities, visual or auditory impairment Had history of Botulinum toxin injection on the affected upper extremity for last 6 months or receive the injection during the study time Other treatment options planned on the affected upper extremity during the study time Wear daytime orthosis on the affected limb Zancolli classification of the affected hand was grade III. Got an epilepsy or convulsive condition Denied to give the informed consent or continue the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sivaporn Vongpipatana
    Organizational Affiliation
    Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodi Hospital Mahidol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    I plan to share the information about the result of the study with the statistician and some team members for the analysis. The sharing will not be linked to the patient identification.
    IPD Sharing Time Frame
    within 3 months after harvesting the data
    Citations:
    PubMed Identifier
    21122742
    Citation
    Arneson CL, Durkin MS, Benedict RE, Kirby RS, Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS. Prevalence of cerebral palsy: Autism and Developmental Disabilities Monitoring Network, three sites, United States, 2004. Disabil Health J. 2009 Jan;2(1):45-8. doi: 10.1016/j.dhjo.2008.08.001.
    Results Reference
    background
    PubMed Identifier
    16437058
    Citation
    Bhasin TK, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 years--Metropolitan Atlanta Developmental Disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Summ. 2006 Jan 27;55(1):1-9. Erratum In: MMWR Morb Mortal Wkly Rep. 2006 Feb 3;55(4):105-6.
    Results Reference
    background
    PubMed Identifier
    16765723
    Citation
    Paneth N, Hong T, Korzeniewski S. The descriptive epidemiology of cerebral palsy. Clin Perinatol. 2006 Jun;33(2):251-67. doi: 10.1016/j.clp.2006.03.011.
    Results Reference
    background
    PubMed Identifier
    12227618
    Citation
    Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40.
    Results Reference
    background
    PubMed Identifier
    24819682
    Citation
    Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046.
    Results Reference
    background
    Citation
    Samia Abdel Rahman, Abdel Rahman, Afaf A. Shaheen. Virtual Reality Use in Motor Rehabilitation of Neurological Disorders: A Systematic Review. Middle-East Journal of Scientific Research; 7 (1): 63-70.
    Results Reference
    background
    PubMed Identifier
    17895352
    Citation
    Chen YP, Kang LJ, Chuang TY, Doong JL, Lee SJ, Tsai MW, Jeng SF, Sung WH. Use of virtual reality to improve upper-extremity control in children with cerebral palsy: a single-subject design. Phys Ther. 2007 Nov;87(11):1441-57. doi: 10.2522/ptj.20060062. Epub 2007 Sep 25.
    Results Reference
    background
    PubMed Identifier
    21978233
    Citation
    Green D, Wilson PH. Use of virtual reality in rehabilitation of movement in children with hemiplegia--a multiple case study evaluation. Disabil Rehabil. 2012;34(7):593-604. doi: 10.3109/09638288.2011.613520. Epub 2011 Oct 6.
    Results Reference
    background
    Citation
    Pruksananonda C. Cerebral Palsy. In: Prasongjean P, editor. Cerebral Palsy Disease. Bangkok: Chulalongkorn University Printing House; 2010. p. 1-3.
    Results Reference
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    Kinect Sensor in Cerebral Palsy Children: Phase 2.1

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