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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547400
• Other study ID #: 2020-123
• Status: Completed
• Start date: October 5, 2020
• Est. completion date: May 13, 2022

Study information

• Verified date: August 2022
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 13, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• assessment
Assessments of balance, gait, lower extremity position sense, and foot sole sense

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Cattaneo D, Jonsdottir J. Sensory impairments in quiet standing in subjects with multiple sclerosis. Mult Scler. 2009 Jan;15(1):59-67. doi: 10.1177/1352458508096874. Epub 2008 Oct 9. — View Citation

Chung LH, Remelius JG, Van Emmerik RE, Kent-Braun JA. Leg power asymmetry and postural control in women with multiple sclerosis. Med Sci Sports Exerc. 2008 Oct;40(10):1717-24. doi: 10.1249/MSS.0b013e31817e32a3. — View Citation

Eils E, Behrens S, Mers O, Thorwesten L, Völker K, Rosenbaum D. Reduced plantar sensation causes a cautious walking pattern. Gait Posture. 2004 Aug;20(1):54-60. — View Citation

Roll R, Kavounoudias A, Roll JP. Cutaneous afferents from human plantar sole contribute to body posture awareness. Neuroreport. 2002 Oct 28;13(15):1957-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait	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	5 minutes
Primary	Balance	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.	10 minutes
Secondary	Light touch-pressure sensation	Light touch-pressure sensation will be assessed using a full Semmes-Weinstein Monofilament (SWM) test kit (North Coast Medical, San Jose, CA, USA).	10 minutes
Secondary	Vibration sensation	Duration of vibration sensation will be measured using 128-Hz frequency tuning fork (Elcon1 Medical Instruments, Tuttlingen, Germany).	10 minutes
Secondary	Two-point discrimination	Two-point discrimination sensation of the foot sole will be evaluated using an aesthesiometer (Baseline1, White Plains, New York, USA).	10 minutes
Secondary	position sensation of knee joint	Open kinetic chain position of both knees will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA).	5 minutes
Secondary	Knee proprioception	Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).	10 minutes