Multiple Sclerosis Clinical Trial
Official title:
An Investigation of Knee Position Sense, Balance, and Dual Task Performance in Different Phases of Menstrual Cycle in Females With Multiple Sclerosis
NCT number | NCT04286828 |
Other study ID # | 2019-17 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 25, 2019 |
Est. completion date | November 26, 2019 |
Verified date | February 2020 |
Source | Ankara Yildirim Beyazit University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | November 26, 2019 |
Est. primary completion date | October 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 26 Years to 49 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara Yildirim Beyazit University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation | Ankara | Esenboga |
Lead Sponsor | Collaborator |
---|---|
Ankara Yildirim Beyazit University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | through study completion, an average of 1 year | |
Primary | 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. |
through study completion, an average of 1 year | |
Primary | 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. | through study completion, an average of 1 year |
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