Kinect Sensor in Cerebral Palsy Children Phase 2.2

Upper Extremity Problem Clinical Trial

Official title:

The Engineer-built System, Video-game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328466
• Other study ID #: MURA2021/768-2.2
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: December 2022

Study information

• Verified date: September 2022
• Source: Mahidol University
• Contact: Sivaporn Vongpipatana, MD.
• Phone: 022011154
• Email: sivaporn.vop[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy Children
• Paralysis
• Upper Extremity Problem

Intervention

Device:
• The engineer-built system, video-game based Kinect sensor
The games were developed by the researcher team.

Locations

Country	Name	City	State
Thailand	Srisangwan School Foundation for the Welfare of the Crippled under Royal Patronage of Her Royal Highness the Princess Mother	Nonthaburi

Sponsors (4)

Lead Sponsor	Collaborator
Mahidol University	Apiphan Iamchaimongkol, Tulyapruek Tawonsawatruk, Warakorn Charoensuk

Country where clinical trial is conducted

Thailand, 

References & 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. — View 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. — View 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. Epub 2007 Sep 25. — View 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. — View 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. — View Citation

Paneth N, Hong T, Korzeniewski S. The descriptive epidemiology of cerebral palsy. Clin Perinatol. 2006 Jun;33(2):251-67. Review. — View Citation

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

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

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	before starting the intervention and after finishing the intervention within 1 week
Secondary	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.	before starting the intervention and after finishing the intervention within 1 week
Secondary	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.	before starting the intervention and after finishing the intervention within 1 week