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

Developmental Delay Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06461572
• Other study ID #: REC/RCR&AHS/23/0790
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: August 29, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Imran Amjad, PHD
• Phone: 9233224390125
• Email: a.javed[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 29, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Developmental Delay
• Refractive Errors

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Pakistan	Riphah international university	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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