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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05978778
Other study ID # REC/RCR&AHS/23/0722
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 27, 2023
Est. completion date September 15, 2023

Study information

Verified date November 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

To determine the effects of active video gaming on pre-hand writing skills of children with down syndrome.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 15, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 14 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
wii sports game
wii sports is a collection five sports game stimulation,which have been designed to demonstrate the motion sensing capabilities of wii remote
Other:
pre-hand writing skills
pre-hand writing skills

Locations

Country Name City State
Pakistan Lingua Speech Model town Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

O'BRIEN JC, O'BRIEN MO. Educational Systems. Pediatric Skills for Occupational Therapy Assistants E-Book. 2020 Jul 12:46.

Outcome

Type Measure Description Time frame Safety issue
Primary pre handwriting skills syndrome. bilateral hand use will determine by box and ball test children with down syndrome. 6 months
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