Multiple SclerosisNCT04750733
Impact of Core Performance on Functional Parameters in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Assessment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2021to 5 Jul 2022
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34147
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Assessment
- Keywords
- Multiple sclerosis, core stability, postural control, isokinetic strength, physical capacity, fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Assessment of core strength and endurance, muscle strength, postural sway in different condition, physical capacity and fatigue
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis | Ambulatory MS patients Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core strength
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.
Measured: Baseline
Core endurance
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.
Measured: Baseline
Postural sway
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.
Measured: Baseline
İsokinetic strength
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.
Measured: Baseline
Secondary outcomes (3)
Physical capacity
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.
Measured: Baseline
Mobility
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.
Measured: Baseline
Fatigue
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start20 Feb 2021
- Primary completion1 Jul 2022
- Study completion5 Jul 2022
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feray Güngör, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750733
- Sponsor's protocol ID
- 59491012-604.01.0
- Status last verified
- Jul 2022
- First submitted
- 7 Feb 2021
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Core Performance on Functional Parameters in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04750733
- Acronym / sponsor ID
- 59491012-604.01.0
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, core stability, postural control, isokinetic strength, physical capacity, fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 11 Feb 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | – | Other: AssessmentAmbulatory MS patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 core strength and endurance, muscle strength, postural sway in different condition, physical capacity and fatigue | Other | Multiple Sclerosis |
Primary outcome
Core strength
Time frame: Baseline
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.
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.
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.
İsokinetic strength
Time frame: Baseline
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.
3 secondary outcomes
Physical capacity
Time frame: Baseline
Mobility
Time frame: Baseline
Fatigue
Time frame: Baseline
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 8 Jul 2022.
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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 Istanbul University - Cerrahpasa 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 5 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 8 Jul 2022. 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?
Core strength (time frame: Baseline). The study lists 4 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 8 Jul 2022.