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NCT Number: NCT04547400

Relationship of Position Sense With Gait and Balance in Patients With Multiple Sclerosis

Balance and gait disturbances are among the most common problems in patients with Multiple Sclerosis (MS). There is evidence of decreased foot sole sensation in MS patients. Studies conducted in healthy individuals have revealed the relationship between balance and foot sole sensation. These studies have demonstrated that sensory feedback from the cutaneous receptors of the foot sole plays an important role in maintaining balance. However, it is not yet known clearly to what extent the sensory impairment seen in MS patients affects balance and gait disorders.

The aim of this study is to examine the relationship between lower extremity position sense and foot sole sense with gait and balance in MS patients.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, Turkey (Türkiye)

About this study

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The balance, gait, lower extremity position sense, and foot sole sense will be evaluated.

The researchers will use t-tests to compare for quantitative variables and chi-square for the categorical variables between groups. In addition, the researchers will examine the correlations between balance, gait, lower extremity position sense, and foot sole using by Pearson bivariate correlations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years of age Having a diagnosis of "Multiple Sclerosis" by a specialist physician Relapse free in the last 3 mounts Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 ) No diagnosis of depression

Exclusion criteria

  • Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research

Treatment and study plan

Assessment

Other

Assessments of balance, gait, lower extremity position sense, and foot sole sense

Primary outcomes

  1. Gait

    Time frame: 5 minutes

    Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.

    Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrica

  2. Balance

    Time frame: 10 minutes

    The Modified Sensory Organization Test, which is performed using computerized posturography, measures postural sway in response to 4 different sensory conditions is measured using a force platform.

Secondary outcomes

  1. Light touch-pressure sensation

    Time frame: 10 minutes

    Light touch-pressure sensation will be assessed using a full Semmes-Weinstein Monofilament (SWM) test kit (North Coast Medical, San Jose, CA, USA).

  2. Vibration sensation

    Time frame: 10 minutes

    Duration of vibration sensation will be measured using 128-Hz frequency tuning fork (Elcon1 Medical Instruments, Tuttlingen, Germany).

  3. Two-point discrimination

    Time frame: 10 minutes

    Two-point discrimination sensation of the foot sole will be evaluated using an aesthesiometer (Baseline1, White Plains, New York, USA).

  4. position sensation of knee joint

    Time frame: 5 minutes

    Open kinetic chain position of both knees will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA).

  5. Knee proprioception

    Time frame: 10 minutes

    Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2020
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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