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Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome

Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome Children

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06943352
Enrollment
22
Registered
2025-04-24
Start date
2025-04-15
Completion date
2025-07-16
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome

Keywords

Interactive Sensory play, Manual Dexterity, Free Play

Brief summary

Down Syndrome is a genetic condition in which a patient has an extra chromosome which is a copy of chromosome 21. It causes physical, cognitive, and behavioral symptoms. The person has difficulty with normal life activities. This study evaluates the effect of interactive sensory play on coordinated hand movements or manual dexterity in children with Down Syndrome. Down syndrome is one of the most common birth defects and causes impairments in the body. The children diagnosed with Down syndrome need great deal of therapies in early childhood so that can live a better life. The objective of this study is to assess the effects of interactive sensory play on manual dexterity in Down syndrome children. The study design will be a Randomized Controlled Trial. The study setting will be Tehsil Headquater hospital Sadiqabad. The study duration will be 10 months after the approval of the synopsis. The Sample Size will be 22 which is calculated by epitools. The sampling technique will be a Non-probability convenient sampling technique. Children who are diagnosed with Down Syndrome will be included. Children with other musculoskeletal and neurological issues will be excluded. Data Collection Tools will be Box and Block test and Pediatric Evaluation of Disability Inventory. Identification and recruitment of the participants with Down syndrome will be done. Participants will be selected through lottery for both groups. Group 1 will use Interactive Sensory play and Group 2 will use Free Play as intervention. The assessor will be blind. The data will be analyzed using SPSS 23.

Interventions

OTHERSensory Bins

The sensory bin is a basket filled with different objects of different shapes, sizes, and textures.

OTHERDrawing and Painting

Colored pencils and watercolors will be used.

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment

Intervention model description

A randomized clinical trial will be performed. Participants of this group will play in a group with sensory bins with other children. The intervention will help children interact with others in society and for improving manual dexterity. According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. After every 2 weeks, the tasks will be upgraded. The free play will be given for 15 minutes and interactive sensory play will be given for 30 minutes. The interventions will be given for 45 minutes in each session. Drawing and painting are involved in free play. Participants of group will play alone. The participants will draw or paint for improving manual dexterity. According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. After every 2 weeks, the tasks will be upgraded. The interventions will be given for 45 minutes in each session.

Eligibility

Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No

Inclusion criteria

* Children with moderate level of mental retardation who are able to follow commands

Exclusion criteria

* • Children with other musculoskeletal and neurological issues. * Children with down syndrome but also have complications such as epilepsy, congenital heart condition.

Design outcomes

Primary

MeasureTime frameDescription
Box and Block testAt the start as baseline data. Again at 6th week and then finally at 12th week.This test is used to measure manual dexterity. This test is simple, cheap and quick. The test can be used for different populations to assess the coordinated movements of the hands. The test-retest reliability on more weak hand is 0.98 and the less weak hand is 0.93.It has good convergent validity as the value is 0.80.
• Pediatric Evaluation of Disability InventoryAt the start as baseline data. Again at 6th week and then finally at 12th week.This is an interviewing tool to assess the independence of the patients to perform different activities using their hands. The reliability that was seen was ranging from 0.18 to 0.94. The value of construct validity was seen to be ranging from 0.64-0.95.
Nine-Hole Peg TestAt the start as baseline data. Again at 6th week and then finally at 12th week.This test is used to assess manual dexterity. This test is easy, simple and quick. This test assess coordinated movements of hands. This test consists of a board with nine holes and square boxes or pegs which are inserted into the holes by the participants. This test can be used for assessment in every population. It has excellent interrater reliability which is equal to 0.75 to 0.99. It has excellent convergent validity that is equal to 0.82.

Contacts

Primary ContactImran Amjad, PhD
imran.amjad@riphah.edu.pk9233224390125
Backup ContactMuhammad Asif Javed, MS-PT
a.javed@riphah.edu.pk923224209422

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026