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NCT Number: NCT06461572

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

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.

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Key information

Conditions

Developmental Delay Communication Disorders Eye Diseases Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Refractive Errors Signs and Symptoms

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah international university

Lahore, Punjab Province, 540000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Therapy

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 along with standard therapy and stability exercises.

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Power Ball on Proximal Muscle Control and Refractive Error in Children With Developmental Delay

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 17, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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