- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05634993
Disability Level and Trunk Control in Individuals With Multiple Sclerosis
February 6, 2025 updated by: Melike Sumeyye Ozen, Hacettepe University
The Relationship Between Disability Level and Trunk Control in Individuals With Multiple Sclerosis
Trunk control disorders are frequently encountered in individuals with MS.
Trunk control is very important for safe and quality movement.
Impairment of trunk control reduces the level of independence of individuals during activities of daily living.
For this reason, it is extremely important to evaluate the trunk in the examination and treatment of individuals.
When the literature was examined, it was seen that studies examining trunk control were insufficient.
Therefore, our study was planned to investigate the relationship between disability level and trunk control in individuals with MS.
Study Overview
Study Type
Observational
Enrollment (Actual)
102
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
-
-
Balıkesir
-
Bandırma, Balıkesir, Turkey
- Melike Sumeyye Ozen
-
-
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
Yes
Sampling Method
Probability Sample
Study Population
The population of the study will consist of patients who applied to the Neurology Outpatient Clinic for outpatient treatment and were diagnosed with Multiple Sclerosis by a neurologist and volunteered to participate in the study.
Description
Inclusion Criteria:
- Being between the ages of 18-65
- Having a definite diagnosis of MS
- Expanded Disability Status Scale (EDSS) score of 8.5 and below
- Not having an attack in the last 3 months
Exclusion Criteria:
- Having another musculoskeletal, cardiovascular, pulmonary, metabolic, or neurological disease severe enough to preclude participation in the study.
- Having severe vision and hearing problems
- The presence of severe cognitive impairment detected by the physician at a level that prevents the tests from being performed.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
MS Group
|
Assessment of disability level and trunk control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Expanded Disability Status Scale
Time Frame: baseline
|
It is used for the follow-up of neurological disability and disease stage in MS patients.
A score of 0 on the scale indicates normal neurological status, while a score of 10 means death due to MS.
The higher the score, the higher the disability level.
|
baseline
|
|
Trunk Impairment Scale
Time Frame: baseline
|
This scale; It consists of 3 sub-headings: static sitting balance, dynamic sitting balance and coordination.
The lowest score that can be obtained from the scale is 0, and the highest score is 23.
The higher the score, the higher the trunk control.
|
baseline
|
|
"Sit-ups" test
Time Frame: baseline
|
This test is used to evaluate the strength of the core stability muscles.
Individuals are asked to flex the trunk while the knees are flexed in the supine position.
The number of repetitions they can do for 30 seconds is recorded.
|
baseline
|
|
Modified "Push-ups" test
Time Frame: baseline
|
This test is used to evaluate the strength of the core stability muscles.
Individuals are asked to raise their body up by extending their elbows while in the prone position.
The number of repetitions they can do for 30 seconds is recorded.
|
baseline
|
|
Lateral bridge test
Time Frame: baseline
|
This test is used to evaluate the endurance of the core stability muscles.
Individuals are asked to lift their bodies on their forearms and toes in the side-lying position and maintain this position.
The time held in the position is recorded.
The test is done separately for the right and left sides.
|
baseline
|
|
Modified "Biering-Sorensen" trunk extension test
Time Frame: baseline
|
This test is used to evaluate the endurance of the core stability muscles.
In the prone position, individuals are asked to hang their upper body over the edge of the bed and slightly extend them while their ankles are supported.
The time held in the position is recorded.
|
baseline
|
|
Trunk flexion test
Time Frame: baseline
|
This test is used to evaluate the endurance of the core stability muscles.
Individuals are asked to stand with their torso at 60º with the floor, and their knees and hips at 90º.
The time held in the position is recorded.
|
baseline
|
|
"Prone Bridge" test
Time Frame: baseline
|
This test is used to evaluate the endurance of the core stability muscles.Individuals are asked to lift their torso up in the prone position while the elbows are flexed, carrying their body weight on their forearms and toes.
The time held in the position is recorded.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
June 1, 2022
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
November 11, 2022
First Submitted That Met QC Criteria
November 23, 2022
First Posted (Actual)
December 2, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 6, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-42
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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