Clinical Factors Associated With Position Sense in Patients With Multiple Sclerosis

Sensory impairment is an important problem for patients with Multiple Sclerosis (MS). Although there is no complete loss of sensation in patients, 80% of patients have a significant sensory impairment. The sensory system plays an important role in providing the feedback required to perform motor tasks. Cutaneous sensation, especially in the sole of the foot, is very important in maintaining balance and gait. There are studies showing decreased foot sole sensation in MS patients. Another sensation that is important during motor tasks is the proprioceptive sensation.

The aim of this study is to examine the relationship between the sensation of foot sole and joint position, clinical features, attention, fatigue, body awareness and physical activity level in patients with MS.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Assessment

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 sensation of foot sole, joint position sensation, attention, fatigue, body awareness, and physical activity level will be evaluated.

The investigators will use t-tests to compare for quantitative variables and chi-square for the categorical variables between groups. In addition, the investigators will examine the correlations between the sensation of the foot sole, joint position sensation, attention, fatigue, body awareness, and physical activity level using Pearson bivariate correlations.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ambulatory sample

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Multiple Sclerosis; MS patients (EDSS: 0-5,5)	Other: Assessment; Assessments of foot sole sensation, joint position sensation, attention, fatigue, body awareness, and physical activity level
Healthy group; Healthy individuals without chronic disease	Other: Assessment; Assessments of foot sole sensation, joint position sensation, attention, fatigue, body awareness, and physical activity level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Knee proprioception	Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).	10 minutes
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
Vibration sensation	Duration of vibration sensation will be measured using 128-Hz frequency tuning fork (Elcon1 Medical Instruments, Tuttlingen, Germany).	10 minutes]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Severity	In the Fatigue Severity Scale (FSS), participants are asked to rate their fatigue level between 1 and 7 in the 9 statements (including motivation, exercise, physical functioning, carrying out duties, and interfering with work, family, or social life) during the last week.The minimum score possible is 9 and the highest is 63. The higher score indicates more severe fatigue.	5 minutes
attention	Attention will be evaluated by Trail Making Test.	5 minutes
Physical Activity	Physical Activity will be evaluated using International Physical Activity Questionnaires (IPAQ). The IPAQ measures vigorous-intensity activity, moderate-intensity activity, and walking activity levels by calculating physically active time in regard to the number of days and average time per day in the last week. The activity levels are represented as a Metabolic Equivalent of Tasks (METs) which is the energy expended during sitting at rest. The total score of IPAQ indicates a low physical activity of fewer than 600 MET-minutes per week, moderate physical activity of more than 600 MET-minutes per week, and a high level of physical activity of more than 3000 MET-minutes per week. The higher score indicates a greater physical activity level of the person.	10 minutes
Body Awareness	The Body Awareness Questionnaire is an 18-item scale designed to assess self-reported attentiveness to normal non-emotive body processes, specifically, sensitivity to body cycles and rhythms, ability to detect small changes in normal functioning, and ability to anticipate bodily reactions. Each item is rated ranging from 1 (totally agree) to 7 (totally disagree). The minimum score possible is 18 and the highest is 126. The higher score indicates more awareness of the body.	5 minutes

Collaborators and Investigators

• Sponsor: Gazi University

Publications and helpful links

General Publications

• Sanders EA, Arts RJ. Paraesthesiae in multiple sclerosis. J Neurol Sci. 1986 Jul;74(2-3):297-305. doi: 10.1016/0022-510x(86)90115-2.
• Merchut MP, Gruener G. Quantitative sensory threshold testing in patients with multiple sclerosis. Electromyogr Clin Neurophysiol. 1993 Mar;33(2):119-24.
• Kars HJ, Hijmans JM, Geertzen JH, Zijlstra W. The effect of reduced somatosensation on standing balance: a systematic review. J Diabetes Sci Technol. 2009 Jul 1;3(4):931-43. doi: 10.1177/193229680900300441.
• Eils E, Behrens S, Mers O, Thorwesten L, Volker K, Rosenbaum D. Reduced plantar sensation causes a cautious walking pattern. Gait Posture. 2004 Aug;20(1):54-60. doi: 10.1016/S0966-6362(03)00095-X.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): May 13, 2022
• Study Completion (Actual): May 13, 2022

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; physical activity; fatigue; sensation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2020-122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No