Effects of PEDALS Program Versus Lower Limb Strength Training in Diplegic CP

Not Applicable

Completed

• Conditions: Cerebral Palsy,Diplegic
• Interventions: Other: Pediatric Endurance and Limb Strengthening Program (PEDALS) and Lower Limb Strength Training; Other: Lower Limb Strength Training Group

• Registration Number: NCT05903534
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2023-05-23
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-15
• Primary Completion: 2023-08-31
• Study Completion: 2023-09-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pediatric Endurance and Limb Strengthening Program (PEDALS) Group	Pediatric Endurance and Limb Strengthening Program (PEDALS) and Lower Limb Strength Training	In this group patients will performed pediatric endurance and limb strengthening (PEDALS) program. The stationary cycling intervention was performed 60 min per day, 3 times per week, for a total of 24 sessions, within a 8 week period. The longer session duration was designed to allow adequate rest intervals between set (1-3 minutes). A generalized stretching program was performed prior to cycling.
Lower Limb Strength Training Group	Lower Limb Strength Training Group	In this group patients will performed lower limb strengthening intervention was performed 3 times per week, for a total of 24 sessions, within a 8 week period using the functional strength training (for eccentric, concentric, and isometric contraction), plyometric exercises (including jumping), and balance training. Before each training session, there was a warm-up period with 5 to 10 minutes of dynamic activities (eg, jogging). After training, there was a cool down period with 5 to 10 minutes of dynamic stretching exercises. In addition to rest intervals, after each training session, there was a rest interval to prevent muscle fatigue and injury

Primary Outcome Measures

Name	Time	Method
Goniometer	8 weeks	It will measure lower limb range of motion
Gross motor function measure 88	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	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

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Lahore, Punjab, Pakistan