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Clinical Trials/NCT06637579
NCT06637579
Recruiting
N/A

Effects of Universal Exercise Unit Therapy With Task-oriented Training on Lower Extremity Gross Motor Function and Balance in Cerebral Palsy Children

Riphah International University1 site in 1 country80 target enrollmentJanuary 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy Children
Sponsor
Riphah International University
Enrollment
80
Locations
1
Primary Endpoint
GMFM 88 (gross motor function measure)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Cerebral palsy is a problem that affects the development and motor skills caused by early non-progressive central nervous system damage. Muscle rigidity, spasticity, fragility, uncontrolled movement, or a combination of these abnormalities characterized it. Therapeutic usage of the universal exercise unit is common. Also called a spider cage or monkey cage. This device helps people with motor problems, especially cerebral palsy. This metal 3-dimensional contraption uses wires, rubber bands, pulleys, weights, and belts. The goal is to engage the vestibular and proprioceptive systems, which are necessary for balance, coordination, and awareness.

Detailed Description

A Randomized Clinical Trial (RCT) design will be employed, conducted at the Sialkot Medical and Physiotherapy Center over 10 months following synopsis approval. The anticipated sample size, accounting for a 20% attrition rate, will be 34 participants in each of the two study groups. Group A will undergo Universal Exercise Unit (UEU) therapy along with task oriented training, while Group B will receive task-oriented training for gross motor functioning. The sampling technique will be Non-probability convenience sampling, with inclusion criteria comprising children aged 5-15 diagnosed with spastic cerebral palsy, of both genders and in stable health condition. The data collection tools include the Gross Motor Function Measure 88 (GMFM 88), Trunk Impairment Scale (TIS) and pediatric balance scale. The analysis will be conducted using SPSS for Windows software version 25. Training sessions, lasting 6 weeks, will be conducted twice a week, and data will be collected before and after each session. The UEU therapy will focus on various movements facilitated by the equipment, while the task-oriented training will be personalized, targeting specific functional limitations through activities simulating daily tasks.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
November 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children who were spastic and able to understand and follow commands. Children aged 5-15 years old. Gross Motor Function Classification System (GMFCS) level I-III. Youngsters are capable of walking and standing on their own.

Exclusion Criteria

  • Children with severe physical limitations and disabilities. Children with planned surgeries in the next 6 months. Any musculoskeletal or orthopedic conditions limiting participation in exercise programs.
  • Kids with planned surgical or medical surgeries during the study period. Children with impaired cognition. Children with hearing impairment and visual impairment.

Outcomes

Primary Outcomes

GMFM 88 (gross motor function measure)

Time Frame: 6 weeks

GMFM is an assessment tool used to evaluate and measure gross motor function in CP

TIS (trunk impairment scale)

Time Frame: 6 weeks

TIS is a clinical assessment tool designed to evaluate trunk control

Pediatric Berg Balance Scale

Time Frame: 6 weeks

The Pediatric Balance Scale is used to assess functional balance skills in school-aged children

Study Sites (1)

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