Kinect Sensor in Cerebral Palsy Children Phase 2.2

NCT ID: NCT05328466

Last Updated: 2022-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2022-12-31

Brief Summary

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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".

Detailed Description

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Conditions

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Cerebral Palsy Children Upper Extremity Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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video game in CP children

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.

Group Type EXPERIMENTAL

The engineer-built system, video-game based Kinect sensor

Intervention Type DEVICE

The games were developed by the researcher team.

Conventional therapy

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The engineer-built system, video-game based Kinect sensor

The games were developed by the researcher team.

Intervention Type DEVICE

Other Intervention Names

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conventional occupational therapy program

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Warakorn Charoensuk

UNKNOWN

Sponsor Role collaborator

Apiphan Iamchaimongkol

UNKNOWN

Sponsor Role collaborator

Tulyapruek Tawonsawatruk

UNKNOWN

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Sivaporn Vongpipatana

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sivaporn Vongpipatana

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodi Hospital Mahidol University

Locations

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

Nonthaburi, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Sivaporn Vongpipatana, MD.

Role: CONTACT

022011154

Apiphan Iamchaimongkol, MD.

Role: CONTACT

022011154

Facility Contacts

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Amprai Surit, occupational therapist

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21122742 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16437058 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16765723 (View on PubMed)

Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40.

Reference Type BACKGROUND
PMID: 12227618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24819682 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 17895352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21978233 (View on PubMed)

Pruksananonda C. Cerebral Palsy. In: Prasongjean P, editor. Cerebral Palsy Disease. Bangkok: Chulalongkorn University Printing House; 2010. p. 1-3.

Reference Type BACKGROUND

Other Identifiers

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MURA2021/768-2.2

Identifier Type: -

Identifier Source: org_study_id

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