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

NCT ID: NCT05903534

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2023-09-15

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.

Conditions

Cerebral Palsy,Diplegic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pediatric Endurance and Limb Strengthening Program (PEDALS) Group

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.

Group Type: ACTIVE_COMPARATOR

Pediatric Endurance and Limb Strengthening Program (PEDALS) and Lower Limb Strength Training

Intervention Type: OTHER

Pediatric Endurance and Limb Strengthening Program (PEDALS) Group This will receive stationary cycling

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

Group Type: ACTIVE_COMPARATOR

Lower Limb Strength Training Group

Intervention Type: OTHER

Lower Limb Strength Training Group

Interventions

Pediatric Endurance and Limb Strengthening Program (PEDALS) and Lower Limb Strength Training

Pediatric Endurance and Limb Strengthening Program (PEDALS) Group This will receive stationary cycling

Intervention Type: OTHER

Lower Limb Strength Training Group

Lower Limb Strength Training Group

Intervention Type: OTHER

Other Intervention Names

This will receive functional strength training, plyometric, balance training

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iqra Mahnoor

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

Fowler EG, Knutson LM, Demuth SK, Siebert KL, Simms VD, Sugi MH, Souza RB, Karim R, Azen SP; Physical Therapy Clinical Research Network (PTClinResNet). Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):367-81. doi: 10.2522/ptj.20080364. Epub 2010 Jan 21.

Reference Type: BACKGROUND

PMID: 20093327 (View on PubMed)

Other Identifiers

REC/RCR&AHS/23/0702

Identifier Type: -

Identifier Source: org_study_id