Clinical trial NCT05328466: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy Children
Upper Extremity Problem
Keywords: video-game
Kinect sensor
upper extremities problems
cerebral palsy
children
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Warakorn Charoensuk
name: Apiphan Iamchaimongkol
name: Tulyapruek Tawonsawatruk
First posted: 2022-04-14
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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".


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

Primary outcomes:
measure: range of motion
timeFrame: before starting the intervention and after finishing the intervention within 1 week
Secondary outcomes:
measure: Box and block test
timeFrame: before starting the intervention and after finishing the intervention within 1 week
measure: ABILHANDS-Kids
timeFrame: before starting the intervention and after finishing the intervention within 1 week
measure: EQ-5D-Y
timeFrame: before starting the intervention and after finishing the intervention within 1 week
Other outcomes:
Locations:
city: Nonthaburi
country: Thailand
facility: Srisangwan School Foundation for the Welfare of the Crippled under Royal Patronage of Her Royal Highness the Princess Mother
Study officials:
affiliation: Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodi Hospital Mahidol University
name: Sivaporn Vongpipatana
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40.
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.
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.
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.
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.
citation: Pruksananonda C. Cerebral Palsy. In: Prasongjean P, editor. Cerebral Palsy Disease. Bangkok: Chulalongkorn University Printing House; 2010. p. 1-3.