search
Back to results

Effects of Active Video Gaming on Pre-handwriting Skills of Children With Down Syndrome.

Primary Purpose

Down Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
wii sports game
pre-hand writing skills
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome

Eligibility Criteria

5 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 5 to 14 years. Both male and female patient diagnosed with down syndrome. Able to understand and follow verbal command. Down syndrome children with pre-hand writing skills are not good. Difficulty in fine motor skills. Exclusion Criteria: Patients will have any neurological sign (epilepsy, instability of the atlantoaxial joint, cardiac anomalies, vision and hearing loss, speech loss. Musculoskeletal and mobility disorder.

Sites / Locations

  • Lingua Speech Model townRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

controlled group

Experimental group

Arm Description

Nine children will be randomly allocated to control group who receive only pre-hand writing skills.

Nine children will be randomly allocated to experimental group who receive active video gaming along with pre-hand writing skills.

Outcomes

Primary Outcome Measures

pre handwriting skills syndrome.
bilateral hand use will determine by box and ball test children with down syndrome.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2023
Last Updated
August 4, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05978778
Brief Title
Effects of Active Video Gaming on Pre-handwriting Skills of Children With Down Syndrome.
Official Title
Effects of Active Video Gaming on Pre-handwriting Skills of Children With Down Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (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 a genetic disorder caused by trisomy 21. Down's syndrome is most common genetic mental disability that affects children physically, mentally and functionally. It occurs due to an extra copy of chromosome 21. It involves a slightly flattened facial profile, low muscle tone upward-slanted eyes, and ligamentous laxity. Central hypotonia, mental retardation and short stature are very common features of children with down's syndrome. Children with down's syndrome are characterized by awkward movements, gait, increased flexibility of joints, timing of mastering of basic skills and , under-development of fine motor skills. Active video gaming used different games that involve interactive session that can enhance cortical recognition, motor learning and functional profile of children with DS. The objective of this study is to determine the effects of active video gaming on pre-hand writing skills of children with down's syndrome. This will be a RCT(Randomized Controlled Trial).The sample size was 18 and the study design was a case-control trial. The inclusion criteria are children with down syndrome age 6 to 12 years both male and female patients are randomly selected and children with poor pre-hand writing skills. And the exclusion criteria for this study is children with any other neurological condition like (epilepsy, instability of atlantoaxial joints, cardiac anomalies,) vision, and hearing loss. Two groups were randomly assigned and equally divided patients into each group. Group A received pre-handwriting skills, like tracing alphabets and numbers, scribbling, coloring, painting, and group B received active video gaming and prehandwriting skills. For measuring each group developmental coordination disorder questionnaire tool is used. The session will be taken 30 mins thrice a week for (8consecutive weeks). Data collected from different centers, Raising sun institute of special education. Autism resource center Lahore. SPSS for Windows software, version 25 will be used to analyze the data using statistical Significance p=0.05. The Shapiro-Wilk test will be used to check the normality of data. Keywords: Active video gaming, Down syndrome, Computer game, Fine motor skills, Pre-hand writing skills, Virtual reality gaming.
Detailed Description
To determine the effects of active video gaming on pre-hand writing skills of children with down syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Effects of active video gaming on pre-handwriting skills of children with down's syndrome.
Masking
Participant
Masking Description
Effects of active video gaming on pre-handwriting skills of children with down's syndrome.
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
controlled group
Arm Type
Other
Arm Description
Nine children will be randomly allocated to control group who receive only pre-hand writing skills.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Nine children will be randomly allocated to experimental group who receive active video gaming along with pre-hand writing skills.
Intervention Type
Device
Intervention Name(s)
wii sports game
Other Intervention Name(s)
video gaming
Intervention Description
wii sports is a collection five sports game stimulation,which have been designed to demonstrate the motion sensing capabilities of wii remote
Intervention Type
Other
Intervention Name(s)
pre-hand writing skills
Intervention Description
pre-hand writing skills
Primary Outcome Measure Information:
Title
pre handwriting skills syndrome.
Description
bilateral hand use will determine by box and ball test children with down syndrome.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 5 to 14 years. Both male and female patient diagnosed with down syndrome. Able to understand and follow verbal command. Down syndrome children with pre-hand writing skills are not good. Difficulty in fine motor skills. Exclusion Criteria: Patients will have any neurological sign (epilepsy, instability of the atlantoaxial joint, cardiac anomalies, vision and hearing loss, speech loss. Musculoskeletal and mobility disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Asif Javed, ms
Phone
03224209422
Email
a.javed@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nageen Zahra, ms
Organizational Affiliation
Ripha International Univerity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lingua Speech Model town
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
O'BRIEN JC, O'BRIEN MO. Educational Systems. Pediatric Skills for Occupational Therapy Assistants E-Book. 2020 Jul 12:46.
Results Reference
background

Learn more about this trial

Effects of Active Video Gaming on Pre-handwriting Skills of Children With Down Syndrome.

We'll reach out to this number within 24 hrs