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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: assessment

• Registration Number: NCT04547400
• Lead Sponsor: Gazi University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-09-06
• Study First Submitted QC: 2020-09-06
• Study First Posted: 2020-09-14
• Study Start: 2020-10-05
• Primary Completion: 2022-05-13
• Study Completion: 2022-05-13
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Multiple Sclerosis	assessment	MS patients (EDSS: 0-5,5)
Healthy group	assessment	Healthy individuals without chronic disease

Primary Outcome Measures

Name	Time	Method
Balance	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.
Gait	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

Secondary Outcome Measures

Name	Time	Method
Light touch-pressure sensation	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).
Vibration sensation	10 minutes	Duration of vibration sensation will be measured using 128-Hz frequency tuning fork (Elcon1 Medical Instruments, Tuttlingen, Germany).
Knee proprioception	10 minutes	Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).
Two-point discrimination	10 minutes	Two-point discrimination sensation of the foot sole will be evaluated using an aesthesiometer (Baseline1, White Plains, New York, USA).
position sensation of knee joint	5 minutes	Open kinetic chain position of both knees will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA).

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey