Clinical trial NCT06943352: Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome
Official title: Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Interactive Sensory play
Manual Dexterity
Free Play
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Box and Block test
timeFrame: At the start as baseline data. Again at 6th week and then finally at 12th week.
measure: • Pediatric Evaluation of Disability Inventory
timeFrame: At the start as baseline data. Again at 6th week and then finally at 12th week.
measure: Nine-Hole Peg Test
timeFrame: At the start as baseline data. Again at 6th week and then finally at 12th week.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Riphah International University
name: Taiba Hussain, MS-PPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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).