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Position Sense, Balance, and Dual Task Performance at the Menstrual Cycle in Females With Multiple Sclerosis

Completed
Conditions
Multiple Sclerosis
Neurologic Symptoms
Menstrual Cycle
Interventions
Other: Position Sense
Other: Balance
Other: Dual Task Performance
Registration Number
NCT04286828
Lead Sponsor
Ankara Yildirim Beyazıt University
Brief 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 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
27
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Females with Multiple SclerosisBalancePatients with confirmed diagnosis of clinically definite MS and physician-administered EDSS range of 1-3.5.
Healthy FemalesPosition Sense20 healthy volunteers with matching ages and genders.
Females with Multiple SclerosisPosition SensePatients with confirmed diagnosis of clinically definite MS and physician-administered EDSS range of 1-3.5.
Healthy FemalesBalance20 healthy volunteers with matching ages and genders.
Females with Multiple SclerosisDual Task PerformancePatients with confirmed diagnosis of clinically definite MS and physician-administered EDSS range of 1-3.5.
Healthy FemalesDual Task Performance20 healthy volunteers with matching ages and genders.
Primary Outcome Measures
NameTimeMethod
Dual Task Performancethrough 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.

Knee position sensethrough 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.

Balancethrough 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

🇹🇷

Ankara, Esenboğa, Turkey

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