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

Primary Purpose

Cerebral Palsy,Diplegic

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pediatric Endurance and Limb Strengthening Program (PEDALS) and Lower Limb Strength Training
Lower Limb Strength Training Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy,Diplegic focused on measuring Cerebral palsy, endurance, strength, training, pediatric

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah International UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pediatric Endurance and Limb Strengthening Program (PEDALS) Group

Lower Limb Strength Training Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Goniometer
It will measure lower limb range of motion
Gross motor function measure 88
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
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

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
July 12, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05903534
Brief Title
Effects of PEDALS Program Versus Lower Limb Strength Training in Diplegic CP
Official Title
Effects of Pediatric Endurance and Limb Strengthening (PEDALS) Program Versus Lower Limb Strength Training in Diplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy,Diplegic
Keywords
Cerebral palsy, endurance, strength, training, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Its a randomized control trial, used to evaluate the comparative effects of pediatric endurance and limb strengthening program with lower limb strength training in diplegic cerebral palsy. Subjects with diplegic cerebral palsy (GMFCS level 1-11) meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique
Masking
Participant
Masking Description
Participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatment
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pediatric Endurance and Limb Strengthening Program (PEDALS) Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lower Limb Strength Training Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Pediatric Endurance and Limb Strengthening Program (PEDALS) and Lower Limb Strength Training
Intervention Description
Pediatric Endurance and Limb Strengthening Program (PEDALS) Group This will receive stationary cycling
Intervention Type
Other
Intervention Name(s)
Lower Limb Strength Training Group
Other Intervention Name(s)
This will receive functional strength training, plyometric, balance training
Intervention Description
Lower Limb Strength Training Group
Primary Outcome Measure Information:
Title
Goniometer
Description
It will measure lower limb range of motion
Time Frame
8 weeks
Title
Gross motor function measure 88
Description
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
Time Frame
8 weeks
Title
Six minute walk test
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
+923224390125
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Asif Javed, MS
Phone
+923224209422
Email
a.javed@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqra Mahnoor
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20093327
Citation
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.
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Effects of PEDALS Program Versus Lower Limb Strength Training in Diplegic CP

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