NCT06531213

Brief Summary

A second copy of chromosome 21 results in Trisomy 21, a genetic disorder commonly referred to as Down syndrome. In addition to physical traits like low muscular tone, upward-slanting eyes, and a flat facial profile, this extra genetic material causes intellectual and developmental difficulties. Even though people with Down syndrome may experience a range of health problems, they can lead happy, fulfilling lives if they receive the right support and care. Individual differences in the illness's severity are significant. There will be a randomized control trial. People with Down syndrome who are five to nine years old will be screened for this study. Adults with Down syndrome and severe ID will not be eligible to participate in this study. Participants will be selected using

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

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

June 1, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

June 11, 2024

Last Update Submit

August 13, 2024

Conditions

Keywords

down syndromevisual motor skillsFine motor skillspostural instability

Outcome Measures

Primary Outcomes (2)

  • Berry Visual Motor Integration

    The berry VMI is designed to assess a person's ability to integrate visual and motor skills so that the proper treatment can be provided

    8weeks

  • Bruininks oseretsky test

    BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation.

    8weeks

Study Arms (2)

Group A

EXPERIMENTAL

Visual Perception Activities and usual care group

Other: experimental

Group B

EXPERIMENTAL

Usual Care group (control)

Other: controlled

Interventions

Experimental Group: Baseline rehabilitation, Visual Perception Interventions. Home base activities, Baseline Rehabilitation (Strengthing exercise, achieving missing milestones). Visual Perception Interventions • Puzzle:Give step-by-step • printable activities • Sudoku. SET, Search Word, Spot it, what is missing, Tic Tac Toe, I Spy

Group A

Controlled: Baseline rehabilitation. Home-based activities, Baseline Rehabilitation (strengthening exercise, achieving missing milestones).3. Activities Play Dough ( Manipulation) Draw on sketch Cup stacking.

Also known as: usual control group
Group B

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age ranged between 6-9 years.
  • IQ level mild to moderate (below 40)

You may not qualify if:

  • Heart,
  • GIT problems,
  • respiratory problems
  • and hearing loss.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International university

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Sahin S, Kose B, Aran OT, Bahadir Agce Z, Kayihan H. The Effects of Virtual Reality on Motor Functions and Daily Life Activities in Unilateral Spastic Cerebral Palsy: A Single-Blind Randomized Controlled Trial. Games Health J. 2020 Feb;9(1):45-52. doi: 10.1089/g4h.2019.0020. Epub 2019 Jul 23.

    PMID: 31335174BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Zohaib Saddiquee, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single participant will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: it will be randomized control trail in which nonprobability convenient sampling will be used .two groups 5 to 9 age will be formed in which participants will randomly divided. Experimental Group: Baseline rehabilitation, Visual Perception Interventions. Control Group: Home-based activities, Baseline Rehabilitation (strengthening exercise, achieving missing milestones).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

July 31, 2024

Study Start

June 1, 2024

Primary Completion

July 30, 2024

Study Completion

August 11, 2024

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations