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Clinical Trials/NCT05903534
NCT05903534
Completed
Not Applicable

Effects of Pediatric Endurance and Limb Strengthening (PEDALS) Program Versus Lower Limb Strength Training in Diplegic Cerebral Palsy

Riphah International University1 site in 1 country24 target enrollmentMay 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy,Diplegic
Sponsor
Riphah International University
Enrollment
24
Locations
1
Primary Endpoint
Goniometer
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Cerebral palsy (CP) is a neurodevelopmental disorder is caused by damage to the developing brain and is characterized by abnormalities of muscle tone, mobility, and motor abilities. CP may only be recognized at 3-5 years of age. Pediatric endurance and limb strengthening (PEDALS) program is important to achieve endurance, gross motor function and some measure of strength in patients with diplegic cerebral palsy. The aim of this study is to evaluate the comparative effects of pediatric endurance and limb strengthening program with lower limb strength training in diplegic cerebral palsy.

Detailed Description

A randomized control trial will be conducted through convenient sampling. Subjects will randomly allocated into two groups, group A will receive pediatric endurance and limb strengthening program, while group B will receive lower limb strength training. The duration of the treatment will be 8 weeks. Goniometer, six minute walk test and gross motor function measure scale-88 will be used to as outcome measure. Goniometer measures the available range of motion at a joint, six minute walk test measure cardiorespiratory or aerobic endurance, the GMFM-88 provides more descriptive information about motor function for very young children or children with more complex motor disability, Data will be analyzed on SPSS version 27, normality of the data will be checked and tests will be applied according to the normality of the data either it will be parametric test or non-parametric based on the normality.

Registry
clinicaltrials.gov
Start Date
May 23, 2023
End Date
September 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age between 6-12 years of age, children with cerebral palsy
  • Ability to follow simple verbal direction
  • Ability to walk independently with or without an assistive device for short distance (GMFCS) level 1-11
  • Good or fair selective voluntary motor control for at least one limb

Exclusion Criteria

  • Orthopedic surgery
  • Botulinum toxin injection within the preceding 3 months
  • Serial casting or new orthotic devices within the preceding 3 months
  • Initiation of oral medication that effect the neuromuscular system
  • Significant hip, knee or ankle joint contractures
  • Inability of unwillingness to maintain age- appropriate behavior

Outcomes

Primary Outcomes

Goniometer

Time Frame: 8 weeks

It will measure lower limb range of motion

Gross motor function measure 88

Time Frame: 8 weeks

the GMFM-88: The Gross Motor Function Measure (GMFM-88) is commonly used in the evaluation of gross motor function in children with cerebral palsy (CP). It consists of 88 items that have been categorized into 5 dimensions of gross motor function: lying and rolling; sitting; crawling and kneeling; standing; and walking, running, and jumping. Many studies use GMFM to assess the effectiveness of interventions in children with CP

Six minute walk test

Time Frame: 8 weeks

6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. It is important for rehabilitation providers to assess endurance of children with CP. Clinicians rely on readily available, easily-administered measures to establish a baseline and measure change over time 6-minute walk test (6MWT)are designed for these purposes

Study Sites (1)

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