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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05392322
Other study ID # REC/RCR & AHS/22/0702
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 25, 2021
Est. completion date September 2022

Study information

Verified date September 2022
Source Riphah International University
Contact Fiza Shahzadi, MSPPT
Phone 03097391564
Email fizashehzadi91564@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Down's syndrome is genetic disorder caused by trisomy 21. Children with Down's syndrome are characterized by awkward movements, gait, increased flexibility of joints, timing of mastering of basic skills, under development of fine motor skills. Virtual Reality Therapy (VRT) is a technique that uses interactive games as a physical therapy resource and has shown positive results in cortical reorganization, improving functional mobility, and quality of movement. This is an experimental study in which randomized controlled trials study design is being used.


Description:

Down's syndrome is a genetic disorder caused by trisomy 21. Down's syndrome is characterized by a variety of dysmorphic features, congenital malformations and other health problems and medical conditions. Not all of them are present in each affected individual. The impact of Down's syndrome for each person is variable some are more affected, some are mild affected and some are fully independent.Children with Down's syndrome are characterized by awkward movements, gait, increased flexibility of joints, timing of mastering of basic skills, under development of fine motor skills. Virtual video gaming is a best method for development of fine motor skills in Down's syndrome children. Virtual Reality Therapy (VRT) is a technique that uses interactive games as a physical therapy resource and has shown positive results in cortical reorganization, improving functional mobility, and quality of movement. This is an experimental study in which randomized controlled trials study design is being used. Data will be collected from rising sun institute within 6 months after the approval of synopsis. Randomized sampling method will be used. Sample size will be 16 children with Down's syndrome. One group is Control group (self-help skills) in which only self-help skills effect on fine motor skills in Down's syndrome children will be assessed. Other group is Experimental group (virtual video gaming) in which effect of virtual video gaming on fine motor skills will be assessed. ABILHAND-KIDS tool will be used for measurement of effectiveness of virtual video gaming in children with Down' s syndrome. The objective of study is to determine the effects of virtual reality video gaming on fine motor skills in children with Down' s syndrome.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria: - Age group of patients ranged between 6 years to 10years. - Both the gender will be considered. - Subject who is able to follow the instruct Exclusion Criteria: - Patients with medical co-morbid. - Gross deformity of upper /lower limb - Epilepsy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Self-help skills
Self-help skills were given to down's syndrome children 3 times per week upto 15 minutes.
Device:
Virtual video reality gaming
Virtual video reality gaming was given to children with down's Syndrome 3 time per week upto 15 minutes.

Locations

Country Name City State
Pakistan Rising sun school for special children Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Beqaj S, Tërshnjaku EET, Qorolli M, Zivkovic V. Contribution of Physical and Motor Characteristics to Functional Performance in Children and Adolescents with Down Syndrome: A Preliminary Study. Med Sci Monit Basic Res. 2018 Oct 16;24:159-167. doi: 10.12659/MSMBR.910448. — View Citation

Boato E, Melo G, Filho M, Moresi E, Lourenço C, Tristão R. The Use of Virtual and Computational Technologies in the Psychomotor and Cognitive Development of Children with Down Syndrome: A Systematic Literature Review. Int J Environ Res Public Health. 2022 Mar 3;19(5). pii: 2955. doi: 10.3390/ijerph19052955. Review. — View Citation

Hocking DR, Ardalan A, Abu-Rayya HM, Farhat H, Andoni A, Lenroot R, Kachnowski S. Feasibility of a virtual reality-based exercise intervention and low-cost motion tracking method for estimation of motor proficiency in youth with autism spectrum disorder. J Neuroeng Rehabil. 2022 Jan 7;19(1):1. doi: 10.1186/s12984-021-00978-1. Erratum in: J Neuroeng Rehabil. 2022 Jun 24;19(1):62. — View Citation

Jain PD, Nayak A, Karnad SD, Doctor KN. Gross motor dysfunction and balance impairments in children and adolescents with Down syndrome: a systematic review. Clin Exp Pediatr. 2022 Mar;65(3):142-149. doi: 10.3345/cep.2021.00479. Epub 2021 Jun 11. — View Citation

Klotzbier TJ, Holfelder B, Schott N. Associations of Motor Performance and Executive Functions: Comparing Children with Down Syndrome to Chronological and Mental Age-Matched Controls. Children (Basel). 2022 Jan 5;9(1). pii: 73. doi: 10.3390/children9010073. — View Citation

Silva V, Campos C, Sá A, Cavadas M, Pinto J, Simões P, Machado S, Murillo-Rodríguez E, Barbosa-Rocha N. Wii-based exercise program to improve physical fitness, motor proficiency and functional mobility in adults with Down syndrome. J Intellect Disabil Res. 2017 Aug;61(8):755-765. doi: 10.1111/jir.12384. Epub 2017 Jun 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The abilhand-kids tool The ABILHAND-KIDS tool was developed as a measure of manual ability of children with cerebral palsy. It describes most representative inventory of manual activities. The 21 items of ABILHAND-KIDS defined a valid and reliable manual ability scale. The ABILHAND-KIDS was originally developed by using the Rasch measurement model. It allows to convert ordinal score into linear measure located on unidimensional score. 4th day
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