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Completed

NCT Number: NCT04548297

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Motor Activity Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

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 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.

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"
  • 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

Treatment and study plan

Assessment

Other

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

Primary 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. 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).

  4. 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).

Secondary outcomes

  1. Fatigue Severity

    Time frame: 5 minutes

    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.

  2. attention

    Time frame: 5 minutes

    Attention will be evaluated by Trail Making Test.

  3. Physical Activity

    Time frame: 10 minutes

    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.

  4. Body Awareness

    Time frame: 5 minutes

    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.

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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