Back to resultsEffects of Progressive Resistance Exercise Training on Endurance and Functional Mobility in Children With Spina Bifida
Primary Purpose
Spina Bifida
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional treatment
Progressive resistance exercise
Sponsored by
About this trial
This is an interventional treatment trial for Spina Bifida focused on measuring resistance exercise, endurance, functional mobility
Eligibility Criteria
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
Sites / Locations
- Children hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional treatment
Progressive resistance exercise
Arm Description
Outcomes
Primary Outcome Measures
Patient Specific Functional Scale for lower extremity functional status
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
Secondary Outcome Measures
6 minute walk test
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.
sit to stand test
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
Full Information
NCT ID
NCT05719636
First Posted
January 31, 2023
Last Updated
March 31, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05719636
Brief Title
Effects of Progressive Resistance Exercise Training on Endurance and Functional Mobility in Children With Spina Bifida
Official Title
Effects of Progressive Resistance Exercise Training on Endurance and Functional Mobility in Children With Spina Bifida
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 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
In this research the effects of progressive resistance exercise training on endurance and functional mobility in children with spina bifida are assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spina Bifida
Keywords
resistance exercise, endurance, functional mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Title
Progressive resistance exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
Conventional protocol that involves simple active and passive range of motion exercises of lower limb with positioning for assistive devices was provided
Intervention Type
Other
Intervention Name(s)
Progressive resistance exercise
Intervention Description
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,.
Primary Outcome Measure Information:
Title
Patient Specific Functional Scale for lower extremity functional status
Description
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
Time Frame
6th week
Secondary Outcome Measure Information:
Title
6 minute walk test
Description
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.
Time Frame
6th week
Title
sit to stand test
Description
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
Time Frame
6th Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mishal Shansi, MS
Phone
03319773117
Email
mishalshamsi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fareeha Kausar, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Progressive Resistance Exercise Training on Endurance and Functional Mobility in Children With Spina Bifida
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