Effects of Progressive Resistance Exercise Training on Endurance and Functional Mobility in Children With Spina Bifida

December 26, 2023 updated by: Riphah International University
In this research the effects of progressive resistance exercise training on endurance and functional mobility in children with spina bifida are assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 8 to 16 year.
  • Male and female both are included.
  • Lower extremity weakness (less than 2).
  • Knee and hip flexion contractures

Exclusion Criteria:

  • Bowel and bladder dysfunction.
  • Children having absent tone.
  • Children having bone fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional treatment
Other: Conventional treatment
Conventional protocol that involves simple active and passive range of motion exercises of lower limb with positioning for assistive devices was provided
Experimental: Progressive resistance exercise
Other: Progressive resistance exercise
The protocol that was applied on the members of (experimental group) are progressive resistance exercises. These passive resistance exercises included Flexion, Extension, Abduction, Adduction of hip; Flexion, Extension of knee; with minimum time in start and minimum quantity of loads, with Thera bands and sandbags,.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Specific Functional Scale for lower extremity functional status
Time Frame: 6th week
Patient Specific Functional Scale (PSFS) was developed by Stratford et al 1995 as a self-report outcome measure of function that could be used in patients with varying levels of independence. The aim of PSFS is to provide clinicians with a valid, reliable, responsive and efficient outcome measure that would be easy to use and applicable to a large number of clinical presentations. Gives the patient positive re-enforcement that the intervention is effective. Can be used on a wide variety of musculoskeletal and neurological conditions
6th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minute walk test
Time Frame: 6th week
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
6th week
sit to stand test
Time Frame: 6th Week
The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand. While monitoring the participant's performance to ensure proper form, the tester silently counts the completion of each correct stand
6th Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Fareeha Kausar, MS, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2022

Primary Completion (Actual)

April 15, 2023

Study Completion (Actual)

April 20, 2023

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 9, 2023

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/22/0740

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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