Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome

NCT06943352 | Not Yet Recruiting DMC

• 1 other identifier: REC/RCR/AHS/25/taiba hussain
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Down Syndrome

Keywords

Interactive Sensory play; Manual Dexterity; Free Play

Outcome Measures

Primary Outcomes (3)

• Box and Block test

  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.

  At the start as baseline data. Again at 6th week and then finally at 12th week.

• • Pediatric Evaluation of Disability Inventory

  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.

  At the start as baseline data. Again at 6th week and then finally at 12th week.

• Nine-Hole Peg Test

  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.

  At the start as baseline data. Again at 6th week and then finally at 12th week.

Study Arms (2)

Interactive Sensory play with Free Play Group

EXPERIMENTAL

Participants of this group will play in a group with sensory bins with other children. The sensory bin is a basket filled with different objects of different shapes, sizes, and textures. The intervention will help children interact with others in society and for improving manual dexterity. The children play in group and alone also for this group. According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. At first, small and easy tasks will be given and 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.

Other: Sensory Bins; Other: Drawing and Painting

Free Play Group

ACTIVE COMPARATOR

Drawing and painting are involved in free play. Participants of this group will play alone. The participants will draw or paint for improving manual dexterity. According to the FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. At first, small and easy tasks will be given and after every 2 weeks, the tasks will be upgraded. The interventions will be given for 45 minutes in each session.

Other: Drawing and Painting

Interventions

Sensory Bins OTHER

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

Interactive Sensory play with Free Play Group

Drawing and Painting OTHER

Colored pencils and watercolors will be used.

Free Play Group; Interactive Sensory play with Free Play Group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Related Publications (1)

• Jarusriboonchai P, Meissner JL, Almeida T, Balaam M. Understanding children's free play in primary schools. InProceedings of the 9th International Conference on Communities & Technologies-Transforming Communities 2019 Jun 3 (pp. 178-188).

  BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Taiba Hussain, MS-PPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

9233224390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: April 15, 2025
• Primary Completion: April 15, 2025
• Study Completion: July 16, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share