Effects of Power Ball on Proximal Muscle and Refractive Errors in Developmental Delay.

NCT ID: NCT06461572

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2024-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

When a child does not meet developmental milestones at the anticipated times, it is referred to as having a developmental delay. These benchmarks cover social, emotional, cognitive, physical, and communication abilities. Developmental delays can result from a number of factors, including genetic circumstances, early delivery, specific medical issues, or external variables. Although they mainly impair vision, refractive errors are unrelated to developmental delays. Because vision facilitates interaction with the environment, it is vital to a child's development. Early detection of uncorrected refractive defects and related vision loss in children can pose a challenge. To ascertain whether an increase is suitable and successful, a thorough evaluation of the child's readiness and the application of pertinent measurement techniques may be necessary. An analysis looks into Randomized Controlled Trial will be the type of study design used. There will be two groups of conveniently randomized sample size of thirty-two. The data analysis will be done using SPSS version 22.0. To verify normality, the Shapiro-Wilk test will be employed. The study will be carried out in the department of physical therapy of the rising sun and the Lahore rehab facility. The study will be finished six months from the time the synopsis is approved. A sample size of thirty-two was determined using the OPENEPI tool. The VQOL/item Tool and pediatric manual muscle testing will be used. For four weeks, the control group will receive standard physical therapy care. Group B: Experimental Group: For five weeks, a traditional physical therapy regimen and Powerball exercises will be administered.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Developmental Delay

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It will be randomized control trial in which non probability convenient sampling will be used. two groups of 7-12 years of age will be perform in which participants will be randomly divided. Group A will receive conventional therapy. Group B will receive Together with conventional treatment, this group will engage in power ball exercises for neck stability and strengthening.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

conventional therapy

This group will receive conventional therapy.

Group Type ACTIVE_COMPARATOR

conventional therapy

Intervention Type OTHER

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.

conventional therapy with Standard therapy and stability exercises

This group will receive conventional therapy with standard therapy and stability exercises.

Group Type EXPERIMENTAL

conventional therapy along with standard therapy and stability exercises.

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

conventional therapy along 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Adeela Iqbal, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Riphah international university

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

Schreiber J. Increased intensity of physical therapy for a child with gross motor developmental delay: a case report. Phys Occup Ther Pediatr. 2004;24(4):63-78. doi: 10.1300/j006v24n04_05.

Reference Type BACKGROUND
PMID: 15669670 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/RCR&AHS/23/0790

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.