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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05978778
Recruitment Status : Completed
First Posted : August 7, 2023
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Down Syndrome Device: wii sports game Other: pre-hand writing skills Not Applicable

Detailed Description:
To determine the effects of active video gaming on pre-hand writing skills of children with down syndrome.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Effects of active video gaming on pre-handwriting skills of children with down's

syndrome.
Masking: Single (Participant)
Masking Description:

Effects of active video gaming on pre-handwriting skills of children with down's

syndrome.
Primary Purpose: Treatment
Official Title: Effects of Active Video Gaming on Pre-handwriting Skills of Children With Down Syndrome.
Actual Study Start Date : May 27, 2023
Actual Primary Completion Date : August 31, 2023
Actual Study Completion Date : September 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arms and Interventions
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Arm Intervention/treatment
controlled group
Nine children will be randomly allocated to control group who receive only pre-hand writing skills.
 Other: pre-hand writing skills
pre-hand writing skills
Experimental: Experimental group
Nine children will be randomly allocated to experimental group who receive active video gaming along with pre-hand writing skills.
 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 Name: video gaming

Other: pre-hand writing skills
pre-hand writing skills


Outcome Measures
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Primary Outcome Measures :
  1. pre handwriting skills syndrome. [ Time Frame: 6 months ]
    bilateral hand use will determine by box and ball test children with down syndrome.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05978778


Locations
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Pakistan
Lingua Speech Model town
Lahore, Punjab, Pakistan
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Nageen Zahra, ms Ripha International Univerity
More Information
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Publications:
O'BRIEN JC, O'BRIEN MO. Educational Systems. Pediatric Skills for Occupational Therapy Assistants E-Book. 2020 Jul 12:46.

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT05978778    
Other Study ID Numbers: REC/RCR&AHS/23/0722
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn