Multiple SclerosisNCT05634993
Disability Level and Trunk Control in Individuals With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Assessment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Assessment
- Keywords
- multiple sclerosis, disability level, trunk control
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Assessment of disability level and trunk control
| Study group | Role | What they receive |
|---|---|---|
| MS Group | Not described Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded Disability Status Scale
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.
Measured: baseline
Trunk Impairment Scale
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.
Measured: baseline
"Sit-ups" test
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.
Measured: baseline
Modified "Push-ups" test
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.
Measured: baseline
Lateral bridge test
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.
Measured: baseline
Modified "Biering-Sorensen" trunk extension test
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.
Measured: baseline
Trunk flexion test
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.
Measured: baseline
"Prone Bridge" test
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Bandırma Onyedi Eylül University
- Responsible party
- Principal investigator, Melike Sumeyye Ozen, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634993
- Sponsor's protocol ID
- 2022-42
- Status last verified
- Feb 2025
- First submitted
- 11 Nov 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Disability Level and Trunk Control in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05634993
- Acronym / sponsor ID
- 2022-42
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, disability level, trunk control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Bandırma Onyedi Eylül University
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS Group | – | Other: Assessment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentAssessment of disability level and trunk control | Other | MS Group |
Primary outcome
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.
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.
"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.
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.
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.
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.
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.
"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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expanded Disability Status Scale (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.