NCT05978778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

July 31, 2023

Last Update Submit

November 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • pre handwriting skills syndrome.

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

    6 months

Study Arms (2)

controlled group

OTHER

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

Other: pre-hand writing skills

Experimental group

EXPERIMENTAL

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

Device: wii sports gameOther: pre-hand writing skills

Interventions

wii sports is a collection five sports game stimulation,which have been designed to demonstrate the motion sensing capabilities of wii remote

Also known as: video gaming
Experimental group

pre-hand writing skills

Experimental groupcontrolled group

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients will have any neurological sign (epilepsy, instability of the atlantoaxial joint, cardiac anomalies, vision and hearing loss, speech loss.
  • Musculoskeletal and mobility disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lingua Speech Model town

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

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

    BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Nageen Zahra, ms

    Ripha International Univerity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Effects of active video gaming on pre-handwriting skills of children with down's syndrome.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Effects of active video gaming on pre-handwriting skills of children with down's syndrome.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 7, 2023

Study Start

May 27, 2023

Primary Completion

August 31, 2023

Study Completion

September 15, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations