Clinical trial NCT06461572: Effects of Power Ball on Proximal Muscle and Refractive Errors in Developmental Delay.
Official title: Effects of Power Ball on Proximal Muscle Control and Refractive Error in Children With Developmental Delay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Delay
Keywords: Developmental delay
Refractive error
Power ball
Muscle control
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 32
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: VQOL/ITEM Tool
timeFrame: 4 weeks
measure: Pediatric functional muscle testing
timeFrame: 4 weeks
measure: snellen chart for refractive errors
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah international university
state: Punjab
Study officials:
affiliation: Riphah International University
name: Adeela Iqbal, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.