- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06654583
Effectiveness of Developed Interactive Play Mat In Pediatric Physical Therapy
October 22, 2024 updated by: Muhammad Naveed Babur, Superior University
The proposed study seeks to innovate by harnessing the potential of an interactive play mat, integrating haptic feedback and captivating sensory stimuli, to facilitate and expedite the motor skill development process in children with delayed milestones.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This research endeavors to contribute substantively to the field of pediatric therapy by providing an engaging, effective, and accessible intervention that aligns with the specific needs of this vulnerable population.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Delayed Milestones, 2-5 Years of age
Exclusion Criteria:
- Spina Bifida, Hydrocephalus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interactive Play Mat
|
Use of developed interactive play mat that utilizes haptic feedback vibrations to assist children with delayed milestones in achieving Gross Motor Skills.
The play mat aims to provide a therapeutic and engaging experience by incorporating visuals, sounds, and lights to encourage movement that might otherwise be challenging for these children.
|
|
Experimental: Conventional Physical Therapy
|
Stretching and Strengthening exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross motor function classification system
Time Frame: 12 Months
|
GMFCS looks at movements like sitting and walking, and it provides a a clear description of someone's current motor function, and an idea of what equipment or mobility aids a child or adult may need in the future, like crutches, a walker, or a wheelchair.
GMFCS Level I Can walk indoors and outdoors and climb stairs without using their hands for support.
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Actual)
June 1, 2024
Study Completion (Estimated)
November 15, 2024
Study Registration Dates
First Submitted
October 22, 2024
First Submitted That Met QC Criteria
October 22, 2024
First Posted (Actual)
October 23, 2024
Study Record Updates
Last Update Posted (Actual)
October 23, 2024
Last Update Submitted That Met QC Criteria
October 22, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- MSRSW/Batch-Fall22/743
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.