CClinicalTrials.gg
Status unknownNCT05392322Updated Sep 7, 2022

Effect of Virtual Video Reality Gaming on Fine Motor Skills in Children With Down's Syndrome

An interventional study of Self-help skills and Virtual video reality gaming in Down's Syndrome and Fine Motor Skills, sponsored by Riphah International University. Status unknown at 1 site in Pakistan. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-07.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2021, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Down's Syndrome
  • Fine Motor Skills

Keywords

  • Fine motor skills
  • Down's Syndrome
  • Self- help skills
  • Computer game
03

In context

Down Syndrome

432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.

This study's planned enrollment of 18 is below the median of 36 across 283 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Patients with medical co-morbid.
  • Gross deformity of upper /lower limb
  • Epilepsy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
18 participants (estimated)

Study arms

  • Active comparator
    Self-help skills

    Effect of self-help skills on fine motor skills in children with down's syndrome

    Other: Self-help skills

  • Experimental
    Virtual video reality gaming

    Effects of virtual video reality gaming on fine motor skills in children with down's syndrome

    Device: Virtual video reality gaming

Interventions

  • OtherSelf-help skills

    Self-help skills were given to down's syndrome children 3 times per week upto 15 minutes.

  • DeviceVirtual video reality gaming

    Virtual video reality gaming was given to children with down's Syndrome 3 time per week upto 15 minutes.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4th day

07

Study locations

1 of 1 sites recruiting
  • Rising sun school for special children
    Lahore, Punjab 54792, Pakistan
    • Hafiza Mehjabeen, MSPPT · Contact · hafiza.mehjabeen@riphah.edu.pk · +92 302 6577666
    • Fiza Shahzadi, MSPPT · Principal investigator
    • Hafiza Mehjabeen, MSPPT · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 35270648 ↗
  • 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. doi: 10.1186/s12984-022-01039-x. PubMed 34996473 ↗
  • 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. PubMed 35053698 ↗
  • 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. PubMed 34126707 ↗
  • 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. PubMed 30323163 ↗
  • 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. PubMed 28585394 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05392322
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
May 26, 2022
Start date
Oct 25, 2021
Primary completion
Sep 2022 (estimated)
Completion
Sep 2022 (estimated)
Last update
Sep 7, 2022

Study contacts

Fiza Shahzadi, MSPPT
Contact
fizashehzadi91564@gmail.com
03097391564
Hafiza Mehjabeen, MSPPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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