- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04750733
Impact of Core Performance on Functional Parameters in Multiple Sclerosis
July 7, 2022 updated by: Feray Güngör, Istanbul University - Cerrahpasa (IUC)
Optimal trunk control relies on somatosensory, motor and musculoskeletal integrity, which is often damaged in multiple sclerosis (MS).
Researches on postural control in people with MS (PwMS) have revealed that reduced somatosensory conduction may adversely affect some functions.
PwMS have increased postural sway in upright posture than healthy people.
They move closer and slower when reaching out or taking a step.
Trunk controls are weak and postural responses are delayed.
The activation of core muscles is very important for an effective trunk control.
Because the core region is considered a kinetic link that facilitates the transfer of torque and angular momentum between the upper and lower extremities during body movements.
The decrease in core stability affects both trunk control and the quality of limb movements due to the kinetic chain in the body.
There are a limited number of studies in the literature showing that core stability is reduced in PwMS.
Our knowledge about the effects of this reduction on function in PwMS is very limited.
Study Overview
Detailed Description
The aim of this study is to evaluate core strength and endurance and determine its effect on postural control, knee muscle strength, physical capacity and fatigue parameters in individuals with MS.
Also relationship between these parameters will investigate.
Study Type
Observational
Enrollment (Actual)
50
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
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-
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Istanbul, Turkey, 34147
- Istanbul University-Cerrahpasa
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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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
People with MS followed in the Neurology Department of Bakirkoy Prof. Dr. Mazhar Osman Education and Research Hospital for Psychiatric and Neurological Diseases will be included.
Description
Inclusion Criteria:
- Being diagnosed with MS according to McDonald's criteria
- Disability level less than 6 according to EDSS (Expanded Disability Status Scale) score
- No attacks during the last 3 months
- Being an ambulatory
- Volunteering to participate in the study
Exclusion Criteria:
- Having orthopedic, neurological, psychological, etc. diseases that accompany MS and may affect treatment outcomes
- Doing regular sports
- Being involved in another physiotherapy and rehabilitation program related to MS
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Multiple Sclerosis
Ambulatory MS patients
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Assessment of core strength and endurance, muscle strength, postural sway in different condition, physical capacity and fatigue
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Core strength
Time Frame: Baseline
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Core strength will be evaluated within the scope of core assessment.
Curl-Up and Modified Push-Up test will be used for the evaluation of core strength.
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Baseline
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Core endurance
Time Frame: Baseline
|
Core endurance will be evaluated within the scope of core assessment.
Trunk flexor, extensor, lateral endurance and plank will be used in the evaluation of core endurance and recorded as seconds.
|
Baseline
|
Postural sway
Time Frame: Baseline
|
Postural sways will be evaluated with biodex balance system in different condition such as open eyes on firm and foam surface, closed eyes on firm and foam surface, double stance on firm and foam surface, tandem stance on firm and foam surface.
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Baseline
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İsokinetic strength
Time Frame: Baseline
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Concentric isokinetic muscle strength of the knee flexor and extensor muscles will be evaluated with Biodex isokinetic dynamometer at angular velocities of 30,60 and 90°/s.
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Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical capacity
Time Frame: Baseline
|
Two-minute walk test (2-MWT) will be used to evaluate the mobility of the people with MS. 2-MWT is a measure of self-paced walking ability and functional capacity.
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Baseline
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Mobility
Time Frame: Baseline
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Timed Up and Go (TUG) will be used.
TUG is a test used to determine fall risk and measure the progress of balance, sit to stand and walking.
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Baseline
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Fatigue
Time Frame: Baseline
|
Fatigue Severity Scale (FSS) will be used to evaluate fatigue levels.
This scale evaluates the severity of fatigue with 9 questions.
Each question scores between 1 (I do not agree) and 7 (fully agree).
The FSS score is the average value of nine sections.
A high score indicates increased fatigue severity.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 20, 2021
Primary Completion (Actual)
July 1, 2022
Study Completion (Actual)
July 5, 2022
Study Registration Dates
First Submitted
February 7, 2021
First Submitted That Met QC Criteria
February 10, 2021
First Posted (Actual)
February 11, 2021
Study Record Updates
Last Update Posted (Actual)
July 8, 2022
Last Update Submitted That Met QC Criteria
July 7, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 59491012-604.01.0
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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