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Kinect Sensor in Cerebral Palsy Children Phase 2.2

Primary Purpose

Cerebral Palsy Children, Upper Extremity Problem

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
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

  • Srisangwan School Foundation for the Welfare of the Crippled under Royal Patronage of Her Royal Highness the Princess MotherRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

video game in CP children

Conventional therapy

Arm Description

Children in this arm will play the computer game which was developed by the researcher team 3 session/weeks for 5 weeks. Each session will last for 40 minutes.

children in this arm will receive a conventional program by occupational therapists 3 times/week for 5 weeks. Each session will last for 40 minutes.

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 participants 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
NCT05328466
Brief Title
Kinect Sensor in Cerebral Palsy Children Phase 2.2
Official Title
The Engineer-built System, Video-game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2022 (Actual)
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
Data Monitoring Committee
No

5. Study Description

Brief Summary
There are 3 phase of the study. This registration is phase 2.2. This registration will conduct a randomized controlled trial study in the cerebral palsy children. Due to the limitation of period of time of grant, we changed the study type into pilot-randomization. Our new method of study will collect all of our study which previously separated into pilot and randomized controlled trial in just only one study "pilot-randomization".

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
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
video game in CP children
Arm Type
Experimental
Arm Description
Children in this arm will play the computer game which was developed by the researcher team 3 session/weeks for 5 weeks. Each session will last for 40 minutes.
Arm Title
Conventional therapy
Arm Type
No Intervention
Arm Description
children in this arm will receive a conventional program by occupational therapists 3 times/week for 5 weeks. Each session will last for 40 minutes.
Intervention Type
Device
Intervention Name(s)
The engineer-built system, video-game based Kinect sensor
Other Intervention Name(s)
conventional occupational therapy program
Intervention Description
The games were 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 participants 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

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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sivaporn Vongpipatana, MD.
Phone
022011154
Email
sivaporn.vop@mahidol.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Apiphan Iamchaimongkol, MD.
Phone
022011154
Email
beebie18z@gmail.com
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
Facility Information:
Facility Name
Srisangwan School Foundation for the Welfare of the Crippled under Royal Patronage of Her Royal Highness the Princess Mother
City
Nonthaburi
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amprai Surit, occupational therapist
Email
s_amprai@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
I plan to share the result with the statistician and some researcher for the analysis. The sharing could not be track to the patient identification.
IPD Sharing Time Frame
after harvesting the data within 3 months
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
background

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Kinect Sensor in Cerebral Palsy Children Phase 2.2

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