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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05903534
Collaborator
(none)
24
1
2
3.8
6.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pediatric Endurance and Limb Strengthening Program (PEDALS) and Lower Limb Strength Training
  • Other: Lower Limb Strength Training Group
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 techniqueIts 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:
Single (Participant)
Masking Description:
Participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatment
Primary Purpose:
Treatment
Official Title:
Effects of Pediatric Endurance and Limb Strengthening (PEDALS) Program Versus Lower Limb Strength Training in Diplegic Cerebral Palsy
Actual Study Start Date :
May 23, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Sep 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Other: 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

Active Comparator: 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

Other: Lower Limb Strength Training Group
Lower Limb Strength Training Group
Other Names:
  • This will receive functional strength training, plyometric, balance training
  • Outcome Measures

    Primary Outcome Measures

    1. Goniometer [8 weeks]

      It will measure lower limb range of motion

    2. 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

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: •

    1. Age between 6-12 years of age

    2. Ability to follow simple verbal direction

    3. Ability to walk independently with or without an assistive device for short distance (GMFCS) level 1-11

    4. Good or fair selective voluntary motor control for at least one limb

    Exclusion Criteria:
    1. Orthopedic surgery 2. Botulinum toxin injection within the preceding 3 months 3. Serial casting or new orthotic devices within the preceding 3 months 4. Initiation of oral medication that effect the neuromuscular system 5. Significant hip, knee or ankle joint contractures 6. Inability of unwillingness to maintain age- appropriate behavior

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Riphah International University Lahore Punjab Pakistan

    Sponsors and Collaborators

    • Riphah International University

    Investigators

    • Principal Investigator: Iqra Mahnoor, Riphah International University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Riphah International University
    ClinicalTrials.gov Identifier:
    NCT05903534
    Other Study ID Numbers:
    • REC/RCR&AHS/23/0702
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Riphah International University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 15, 2023