Effects of Universal Exercise Unit Therapy With Task-oriented Training in CP Children

Not Applicable

Recruiting

• Conditions: Cerebral Palsy Children

• Registration Number: NCT06637579
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-10
• Primary Completion: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
GMFM 88 (gross motor function measure)	6 weeks	GMFM is an assessment tool used to evaluate and measure gross motor function in CP
TIS (trunk impairment scale)	6 weeks	TIS is a clinical assessment tool designed to evaluate trunk control
Pediatric Berg Balance Scale	6 weeks	The Pediatric Balance Scale is used to assess functional balance skills in school-aged children

Trial Locations

Locations (1)

Sialkot Medical and Physiotherapy Center; 🇵🇰 Sialkot, Punjab, Pakistan