- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06461572
Effects of Power Ball on Proximal Muscle and Refractive Errors in Developmental Delay.
Effects of Power Ball on Proximal Muscle Control and Refractive Error in Children With Developmental Delay
Study Overview
Status
Conditions
Detailed Description
Group A: conventional physiotherapy will be administered to this group. Manual resistance exercises for neck strengthening are part of conventional physical therapy. Cervical flexion, extension, side flexion, side flexion with rotation, and pure rotation with mild resistance are the exercises used to strengthen the neck. There will be three 30-minute sessions. Strengthening will take place over the course of 15 mints.
Group B: In addition to standard care, this group will engage in power ball exercises for neck stability and strengthening. Gradually, the resistance will rise.
Three mints in each position for a total of fifteen mints of ball exercises. At first, Powerball reduced the pain, progressively strengthened them, and with continued development, allowed them to move in a pain-free range.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 540000
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 7-12 years
- Both genders
- Children with refractive error
- Children with affected developmental delay
Exclusion Criteria:
- Any neurological condition (Epilepsy and seizures)
- Any congenital defects
- Genetic disorder
- Surgery in last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: conventional therapy
This group will receive conventional therapy.
|
This group will receive conventional physiotherapy, which will consist of manual resistance-based neck strengthening exercises.
The exercises will last 30 minutes apiece and cover cervical flexion, extension, side flexion, side flexion with rotation, and pure rotation with moderate resistance.
The power ball's effect on proximal muscle control and refractive error in children with developmental delays will also be discussed.
|
|
Experimental: conventional therapy with Standard therapy and stability exercises
This group will receive conventional therapy with standard therapy and stability exercises.
|
Group B: In addition to standard care, this group will engage in power ball exercises for neck stability and strengthening. Gradually, the resistance will rise. Three mints in each position for a total of fifteen mints of ball exercises. At first, Powerball progressively strengthened the muscle and reduced the pain , and with continued development, allowed them to move in a pain-free range. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VQOL/ITEM Tool
Time Frame: 4 weeks
|
The refractive errors and visual acuity of children who have developmental delays will be assessed using this tool.
The ability of child to identify the size of the letters on a card held 20 feet (6 meters) away or on a standardized chart (Snellen chart).
There will be specific charts used for testing at less than 20 feet (6 meters).
|
4 weeks
|
|
Pediatric functional muscle testing
Time Frame: 4 weeks
|
PFMT will be a useful tool for measurement of muscle strength for children with developmental delay if it be some modifications.
|
4 weeks
|
|
snellen chart for refractive errors
Time Frame: 4 weeks
|
The most popular method for assessing visual acuity in clinical settings is still the Snellen chart.
A handy tool for rapidly evaluating both monocular and binocular visual acuity is the Snellen chart.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adeela Iqbal, MS*, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0790
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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