Kinect Sensor in Cerebral Palsy Children Phase 2.2

NCT05328466 | Unknown

• 1 other identifier: MURA2021/768-2.2
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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".

Conditions

Cerebral Palsy Children; Upper Extremity Problem

Keywords

video-game; Kinect sensor; upper extremities problems; cerebral palsy; children

Outcome Measures

Primary Outcomes (1)

• 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.

  before starting the intervention and after finishing the intervention within 1 week

Secondary Outcomes (3)

• Box and block test

  before starting the intervention and after finishing the intervention within 1 week

• ABILHANDS-Kids

  before starting the intervention and after finishing the intervention within 1 week

• EQ-5D-Y

  before starting the intervention and after finishing the intervention within 1 week

Study Arms (2)

video game in CP children

EXPERIMENTAL

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.

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

Conventional therapy

NO INTERVENTION

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.

Interventions

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

The games were developed by the researcher team.

Also known as: conventional occupational therapy program

video game in CP children

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Warakorn Charoensuk: collaborator
• Apiphan Iamchaimongkol: collaborator
• Tulyapruek Tawonsawatruk: collaborator

Study Sites (1)

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

Nonthaburi, Thailand

RECRUITING

Related Publications (9)

• 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.

  PMID: 21122742 BACKGROUND

• 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.

  PMID: 16437058 BACKGROUND

• 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.

  PMID: 16765723 BACKGROUND

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

  PMID: 12227618 BACKGROUND

• 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.

  PMID: 24819682 BACKGROUND

• 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.

  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.

  PMID: 17895352 BACKGROUND

• 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.

  PMID: 21978233 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sivaporn Vongpipatana

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sivaporn Vongpipatana, MD.

CONTACT

022011154; sivaporn.vop@mahidol.ac.th

Apiphan Iamchaimongkol, MD.

CONTACT

022011154; beebie18z@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 14, 2022
• Study Start: June 9, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: after harvesting the data within 3 months

Locations

TH (1)