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

NCT06461572 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/0790
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Developmental Delay

Keywords

Developmental delay; Refractive error; Power ball; Muscle control

Outcome Measures

Primary Outcomes (3)

• VQOL/ITEM Tool

  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

  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

  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

Study Arms (2)

conventional therapy

ACTIVE COMPARATOR

This group will receive conventional therapy.

Other: conventional therapy

conventional therapy with Standard therapy and stability exercises

EXPERIMENTAL

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

Other: conventional therapy along with standard therapy and stability exercises.

Interventions

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

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.

conventional therapy with Standard therapy and stability exercises

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 7-12 years
• Both genders
• Children with refractive error
• Children with affected developmental delay

You may not qualify if:

• Any neurological condition (Epilepsy and seizures)
• Any congenital defects
• Genetic disorder
• Surgery in last 6 months

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah international university

Lahore, Punjab Province, 540000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 15669670 BACKGROUND

MeSH Terms

Conditions

Learning Disabilities; Refractive Errors

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Eye Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Adeela Iqbal, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: May 20, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 29, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)