Clinical Factors Associated With Position Sense in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Clinical Factors Associated With Position Sense in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548297
• Other study ID #: 2020-122
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• 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"

• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Assessment
Assessments of foot sole sensation, joint position sensation, attention, fatigue, body awareness, and physical activity level

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)

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

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. Review. — View Citation

Merchut MP, Gruener G. Quantitative sensory threshold testing in patients with multiple sclerosis. Electromyogr Clin Neurophysiol. 1993 Mar;33(2):119-24. — View Citation

Sanders EA, Arts RJ. Paraesthesiae in multiple sclerosis. J Neurol Sci. 1986 Jul;74(2-3):297-305. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Vibration sensation	Duration of vibration sensation will be measured using 128-Hz frequency tuning fork (Elcon1 Medical Instruments, Tuttlingen, Germany).	10 minutes]
Primary	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
Primary	Knee proprioception	Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).	10 minutes
Secondary	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
Secondary	attention	Attention will be evaluated by Trail Making Test.	5 minutes
Secondary	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
Secondary	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