- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392322
Effect of Virtual Video Reality Gaming on Fine Motor Skills in Children With Down's Syndrome
Effects of Virtual Video Reality Gaming on Fine Motor Skills in Children With Down's Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fiza Shahzadi, MSPPT
- Phone Number: 03097391564
- Email: fizashehzadi91564@gmail.com
Study Locations
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-
Punjab
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Lahore, Punjab, Pakistan, 54792
- Recruiting
- Rising sun school for special children
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Contact:
- Hafiza Mehjabeen, MSPPT
- Phone Number: +92 302 6577666
- Email: hafiza.mehjabeen@riphah.edu.pk
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Principal Investigator:
- Fiza Shahzadi, MSPPT
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Sub-Investigator:
- Hafiza Mehjabeen, MSPPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Self-help skills
Effect of self-help skills on fine motor skills in children with down's syndrome
|
Self-help skills were given to down's syndrome children 3 times per week upto 15 minutes.
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Experimental: Virtual video reality gaming
Effects of virtual video reality gaming on fine motor skills in children with down's syndrome
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Virtual video reality gaming was given to children with down's Syndrome 3 time per week upto 15 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The abilhand-kids tool
Time Frame: 4th day
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Mehjabeen, MSPPT, Riphah International University
Publications and helpful links
General Publications
- Silva V, Campos C, Sa A, Cavadas M, Pinto J, Simoes P, Machado S, Murillo-Rodriguez 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.
- Boato E, Melo G, Filho M, Moresi E, Lourenco C, Tristao 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):2955. doi: 10.3390/ijerph19052955.
- 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.
- 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):73. doi: 10.3390/children9010073.
- 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.
- Beqaj S, Tershnjaku 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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