Multiple SclerosisNCT04286828
Position Sense, Balance, and Dual Task Performance at the Menstrual Cycle in Females With Multiple Sclerosis
An observational study of Multiple Sclerosis and Neurologic Symptoms, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigation of knee position sense, balance, and dual task performance in different phases of menstrual cycle in females with multiple sclerosis. Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) affecting young people and leading to… Read more about this study
- Who is it for?
- Ages 26 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Neurologic Symptoms, Menstrual Cycle
- What is being tested?
- Position Sense, Balance and Dual Task Performance
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2019to 26 Nov 2019
- 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 26 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: having regular menstrual cycle females with MS and healthy females
Who may be able to join
- Inclusion criteria of the MS group were as follows: patients with a confirmed diagnosis of clinically definite MS, physician-administered Expanded Disability Status Scale (EDSS) range of 1-3.5, and having regular menstrual cycle (between 21-35 days).
- Inclusion criteria of the control group were having regular menstrual cycle, and not having neurological problem, any lower extremity orthopedic problems and no use of any contraceptive agents
Who cannot join
- The exclusion criteria were: patients with acute attacks (three months prior to the study), a Mini-Mental State Examination (MMSE) score of less than 25 points, take oral contraceptive agents, and a history of orthopedic lower extremity problems or other neurological disorders.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
Ankara, Esenboğa, 06970
About this study
Official title: An Investigation of Knee Position Sense, Balance, and Dual Task Performance in Different Phases of Menstrual Cycle in Females With Multiple Sclerosis
The aim of this study was to investigation of knee position sense, balance, and dual task performance in different phases of menstrual cycle in females with multiple sclerosis.
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) affecting young people and leading to demyelination and neurodegeneration. MS affects females more than males with a ratio approximately of 3:1. Important gender differences in progression and inflammatory activity of disease have been observed. Sex hormones have been thought to play an important role in this condition. It is worth noting however that sex hormones not only affect reproduction (menses/pregnancy), they also have direct effects on the nervous and immune system. In the neurologic group, especially in MS patients, it is well known that disease activity, course, and symptoms can be influenced by hormonal fluctuations in different phases of the menstrual cycle. Previous studies have reported that the variation of estrogen and progesterone during the menstrual cycle may have an effect on several neurological functions. However, these studies are mostly subjective, in the form of patient reports and in limited numbers. Smith and Studd reported that there was a premenstrual increase in disease severity as changes in the Th-1 / Th-2 balance occurred in association with decreased circulating estrogen. Withdrawal of hormones from damaged tissues that affect axonal conduction can explain the change in disease activity, course symptoms during the menstrual cycle in female with MS.
For all these reasons,investigators think that different phases of menstrual cycle change position sense, balance, and dual task performance in females with MS. Considering hormonal fluctuations occurring in the menstrual cycle, is an important criterion for organizing the rehabilitation program and evaluation in terms of physiotherapy.
Read the detailed description
The purpose of this study was to determine the effect of hormonal changes on knee position sense, balance and dual task performance throughout the menstrual cycle in females with MS.
14 females with MS and 13 healthy females with matching ages and genders were included the study. A neurologic examination was performed using the EDSS by a neurologist.
Position sense was measured with Acumar dual digital inclinometer (Acu360, Acumar, Lafayette, USA). Balance was measured with Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA). Dual task performance was evaluated with Time Up and Go test.
- Conditions
- Multiple Sclerosis, Neurologic Symptoms, Menstrual Cycle
- Being tested
- Position Sense, Balance, Dual Task Performance
- Keywords
- Multiple Sclerosis, Proprioception, Postural balance, Task performance and analysis
- Medical subject headings
- Multiple Sclerosis, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position SenseOther
Knee position sense was evaluated with a Acumar dual digital inclinometer. Each participant was asked to wear shorts and to lie down in supine position treatment table. The lower extremity of the participant was positioned in neutral for the knee flexion movement. The placement of the digital inclinometer's attachment was the lateral ridge of the femur and tibia. We actively assisted the participant's knee to the target angle and asked the participant to hold it there for 5 seconds before returning the knee to the starting position. After returning to the starting position, participants attempted to repeat the previously attained angle. Participants indicated verbally when they felt they had reached the angle and held their position. This procedure was repeated 3 times for each limb (non-dominant and dominant). We measured the absolute difference between the target angle and the observed angle and calculated the absolute error score by averaging the 3 trials.
BalanceOther
To measure postural stability and Limits of Stability this study used a balance device, the Biodex Balance System.
Postural Stability: The participants were focused on a characteristic dot (COP, centre of pressure) on the monitor screen. The participant's task was to balance the body in such a way that the dot was in the centre of a circle displayed on the monitor at the point of intersection of the coordinate axes. Test consisted of three 20-second trials, each separated by 10-second breaks. Measurements were repeated three times while their eyes were open/close and analyzed by calculating the average value of measurements.
Limits of Stability: The participants are asked to complete the directional tasks displayed on a screen as quickly as possible, with the directions displayed at random. A total of 3 tests were performed, at intervals of 10 s.
Dual Task PerformanceOther
The timed up and go test (TUG) was used in the evaluation of dual task performance. For this test, participants were seated on a standard armless chair and a cone was placed 3 meters away from the chair. Participants were instructed to stand up and (1) walk towards the cone, (2) turn around the cone, (3) walk back to the chair, and (4) sit back on the chair. It was stated that patients should walk without running but as fast as possible. TUG test was performed initially without task, and then with cognitive and motor tasks, respectively. Cognitive task given during the test is counting three backwards from 100 or counting the names starting with the letter "A", and motor task given is to carry three glasses of water on a tray. The time elapses between standing up from the chair and sitting back to chair was recorded as the test result. As time increases, dual task performance decreases.
| Study group | Role | What they receive |
|---|---|---|
| Females with Multiple Sclerosis | Patients with confirmed diagnosis of clinically definite MS and physician-administered EDSS range of 1-3.5. Receives: Other: Position Sense; Other: Balance; Other: Dual Task Performance | |
| Healthy Females | 20 healthy volunteers with matching ages and genders. Receives: Other: Position Sense; Other: Balance; Other: Dual Task Performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee position sense
Knee position sense was evaluated with a Acumar dual digital inclinometer.The absolute error scores (in degrees) for knee flexion at 60° was calculated. As absolute error score increases, position sense decreases.
Measured: through study completion, an average of 1 year
Balance
To measure postural stability and Limits of Stability this study used a balance device, the Biodex Balance System.
Postural Stability: Test consisted of three 20-second trials, each separated by 10-second breaks. Measurements were repeated three times while their eyes were open/close and analyzed by calculating the average value of measurements [30]. As a result, overall stability indexes were taken into account for measurement purposes. For these indexes, a low value indicated high postural stability.
Limits of Stability: The participants are asked to complete the directional tasks displayed on a screen as quickly as possible, with the directions displayed at random. A total of 3 tests were performed, at intervals of 10 second. The test results were used to determine a total score. The higher the total score, the better the ability of the subjects to transfer the centre of gravity.
Measured: through study completion, an average of 1 year
Dual Task Performance
The timed up and go test was used in the evaluation of dual task performance. Timed up and go test was performed initially without task, and then with cognitive and motor tasks, respectively. Cognitive task given during the test is counting three backwards from 100 or counting the names starting with the letter "A", and motor task given is to carry three glasses of water on a tray. The time elapses between standing up from the chair and sitting back to chair was recorded as the test result. As time increases, dual task performance decreases.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start25 Mar 2019
- Primary completion20 Oct 2019
- Study completion26 Nov 2019
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.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286828
- Sponsor's protocol ID
- 2019-17
- Status last verified
- Feb 2020
- First submitted
- 23 Feb 2020
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Knee Position Sense, Balance, and Dual Task Performance in Different Phases of Menstrual Cycle in Females With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04286828
- Acronym / sponsor ID
- 2019-17
- Conditions
- Multiple Sclerosis, Neurologic Symptoms, Menstrual Cycle
- Keywords
- Multiple Sclerosis, Proprioception, Postural balance, Task performance and analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 27 Feb 2020 (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.
The aim of this study was to investigation of knee position sense, balance, and dual task performance in different phases of menstrual cycle in females with multiple sclerosis.
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) affecting young people and leading to demyelination and neurodegeneration. MS affects females more than males with a ratio approximately of 3:1. Important gender differences in progression and inflammatory activity of disease have been observed. Sex hormones have been thought to play an important role in this condition. It is worth noting however that sex hormones not only affect reproduction (menses/pregnancy), they also have direct effects on the nervous and immune system. In the neurologic group, especially in MS patients, it is well known that disease activity, course, and symptoms can be influenced by hormonal fluctuations in different phases of the menstrual cycle. Previous studies have reported that the variation of estrogen and progesterone during the menstrual cycle may have an effect on several neurological functions. However, these studies are mostly subjective, in the form of patient reports and in limited numbers. Smith and Studd reported that there was a premenstrual increase in disease severity as changes in the Th-1 / Th-2 balance occurred in association with decreased circulating estrogen. Withdrawal of hormones from damaged tissues that affect axonal conduction can explain the change in disease activity, course symptoms during the menstrual cycle in female with MS.
For all these reasons,investigators think that different phases of menstrual cycle change position sense, balance, and dual task performance in females with MS. Considering hormonal fluctuations occurring in the menstrual cycle, is an important criterion for organizing the rehabilitation program and evaluation in terms of physiotherapy.
Detailed description
The purpose of this study was to determine the effect of hormonal changes on knee position sense, balance and dual task performance throughout the menstrual cycle in females with MS.
14 females with MS and 13 healthy females with matching ages and genders were included the study. A neurologic examination was performed using the EDSS by a neurologist.
Position sense was measured with Acumar dual digital inclinometer (Acu360, Acumar, Lafayette, USA). Balance was measured with Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA). Dual task performance was evaluated with Time Up and Go test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Females with Multiple Sclerosis | – | Other: Position Sense, Other: Balance, Other: Dual Task PerformancePatients with confirmed diagnosis of clinically definite MS and physician-administered EDSS range of 1-3.5. |
| Healthy Females | – | Other: Position Sense, Other: Balance, Other: Dual Task Performance20 healthy volunteers with matching ages and genders. |
Who may qualify
- Ages
- 26 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- having regular menstrual cycle females with MS and healthy females
Key inclusion criteria (2 listed)
- Inclusion criteria of the MS group were as follows: patients with a confirmed diagnosis of clinically definite MS, physician-administered Expanded Disability Status Scale (EDSS) range of 1-3.5, and having regular menstrual cycle (between 21-35 days).
- Inclusion criteria of the control group were having regular menstrual cycle, and not having neurological problem, any lower extremity orthopedic problems and no use of any contraceptive agents
Key exclusion criteria (1 listed)
- The exclusion criteria were: patients with acute attacks (three months prior to the study), a Mini-Mental State Examination (MMSE) score of less than 25 points, take oral contraceptive agents, and a history of orthopedic lower extremity problems or other neurological disorders.
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 |
|---|---|---|
| Position SenseKnee position sense was evaluated with a Acumar dual digital inclinometer. Each participant was asked to wear shorts and to lie down in supine position treatment table. The lower extremity of the participant was positioned in neutral for the knee flexion movement. The placement of the digital inclinometer's attachment was the lateral ridge of the femur and tibia. We actively assisted the participant's knee to the target angle and asked the participant to hold it there for 5 seconds before returning the knee to the starting position. After returning to the starting position, participants attempted to repeat the previously attained angle. Participants indicated verbally when they felt they had reached the angle and held their position. This procedure was repeated 3 times for each limb (non-dominant and dominant). We measured the absolute difference between the target angle and the observed angle and calculated the absolute error score by averaging the 3 trials. | Other | Females with Multiple Sclerosis, Healthy Females |
| BalanceTo measure postural stability and Limits of Stability this study used a balance device, the Biodex Balance System. Postural Stability: The participants were focused on a characteristic dot (COP, centre of pressure) on the monitor screen. The participant's task was to balance the body in such a way that the dot was in the centre of a circle displayed on the monitor at the point of intersection of the coordinate axes. Test consisted of three 20-second trials, each separated by 10-second breaks. Measurements were repeated three times while their eyes were open/close and analyzed by calculating the average value of measurements. Limits of Stability: The participants are asked to complete the directional tasks displayed on a screen as quickly as possible, with the directions displayed at random. A total of 3 tests were performed, at intervals of 10 s. | Other | Females with Multiple Sclerosis, Healthy Females |
| Dual Task PerformanceThe timed up and go test (TUG) was used in the evaluation of dual task performance. For this test, participants were seated on a standard armless chair and a cone was placed 3 meters away from the chair. Participants were instructed to stand up and (1) walk towards the cone, (2) turn around the cone, (3) walk back to the chair, and (4) sit back on the chair. It was stated that patients should walk without running but as fast as possible. TUG test was performed initially without task, and then with cognitive and motor tasks, respectively. Cognitive task given during the test is counting three backwards from 100 or counting the names starting with the letter "A", and motor task given is to carry three glasses of water on a tray. The time elapses between standing up from the chair and sitting back to chair was recorded as the test result. As time increases, dual task performance decreases. | Other | Females with Multiple Sclerosis, Healthy Females |
Primary outcome
Knee position sense
Time frame: through study completion, an average of 1 year
Knee position sense was evaluated with a Acumar dual digital inclinometer.The absolute error scores (in degrees) for knee flexion at 60° was calculated. As absolute error score increases, position sense decreases.
Balance
Time frame: through study completion, an average of 1 year
To measure postural stability and Limits of Stability this study used a balance device, the Biodex Balance System. Postural Stability: Test consisted of three 20-second trials, each separated by 10-second breaks. Measurements were repeated three times while their eyes were open/close and analyzed by calculating the average value of measurements [30]. As a result, overall stability indexes were taken into account for measurement purposes. For these indexes, a low value indicated high postural stability. Limits of Stability: The participants are asked to complete the directional tasks displayed on a screen as quickly as possible, with the directions displayed at random. A total of 3 tests were performed, at intervals of 10 second. The test results were used to determine a total score. The higher the total score, the better the ability of the subjects to transfer the centre of gravity.
Dual Task Performance
Time frame: through study completion, an average of 1 year
The timed up and go test was used in the evaluation of dual task performance. Timed up and go test was performed initially without task, and then with cognitive and motor tasks, respectively. Cognitive task given during the test is counting three backwards from 100 or counting the names starting with the letter "A", and motor task given is to carry three glasses of water on a tray. The time elapses between standing up from the chair and sitting back to chair was recorded as the test result. As time increases, dual task performance decreases.
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 27 May 2020.
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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 and Neurologic Symptoms, run by Ankara Yildirim Beyazıt 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 2 inclusion and 1 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 27 May 2020. 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?
Knee position sense (time frame: through study completion, an average of 1 year). The study lists 3 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 27 May 2020.