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

Primary Purpose

Down's Syndrome, Fine Motor Skills

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Self-help skills
Virtual video reality gaming
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down's Syndrome focused on measuring Fine motor skills, Down's Syndrome, Self- help skills, Computer game

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rising sun school for special childrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Self-help skills

Virtual video reality gaming

Arm Description

Effect of self-help skills 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
September 5, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05392322
Brief Title
Effect of Virtual Video Reality Gaming on Fine Motor Skills in Children With Down's Syndrome
Official Title
Effects of Virtual Video Reality Gaming on Fine Motor Skills in Children With Down's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down's Syndrome, Fine Motor Skills
Keywords
Fine motor skills, Down's Syndrome, Self- help skills, Computer game

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-help skills
Arm Type
Active Comparator
Arm Description
Effect of self-help skills on fine motor skills in children with down's syndrome
Arm Title
Virtual video reality gaming
Arm Type
Experimental
Arm Description
Effects of virtual video reality gaming on fine motor skills in children with down's syndrome
Intervention Type
Other
Intervention Name(s)
Self-help skills
Intervention Description
Self-help skills were given to down's syndrome children 3 times per week upto 15 minutes.
Intervention Type
Device
Intervention Name(s)
Virtual video reality gaming
Intervention Description
Virtual video reality gaming was given to children with down's Syndrome 3 time per week upto 15 minutes.
Primary Outcome Measure Information:
Title
The abilhand-kids tool
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fiza Shahzadi, MSPPT
Phone
03097391564
Email
fizashehzadi91564@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, MSPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rising sun school for special children
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54792
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, MSPPT
Phone
+92 302 6577666
Email
hafiza.mehjabeen@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Fiza Shahzadi, MSPPT
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, MSPPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35270648
Citation
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.
Results Reference
background
PubMed Identifier
34996473
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.
Results Reference
background
PubMed Identifier
35053698
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):73. doi: 10.3390/children9010073.
Results Reference
background
PubMed Identifier
34126707
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.
Results Reference
background
PubMed Identifier
30323163
Citation
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.
Results Reference
background
PubMed Identifier
28585394
Citation
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.
Results Reference
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Effect of Virtual Video Reality Gaming on Fine Motor Skills in Children With Down's Syndrome

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