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Multiple SclerosisNCT04548297

Clinical Factors Associated With Position Sense in Patients With Multiple Sclerosis

An observational study of Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis
What is being tested?
Assessment
How many people
44 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Oct 2020to 13 May 2022
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: ambulatory sample

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gazi University

    Ankara

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
Assessment
Keywords
Multiple Sclerosis, sensation, fatigue, physical activity
Medical subject headings
Multiple Sclerosis, Fatigue, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AssessmentOther

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

Study groups in NCT04548297
Study groupRoleWhat they receive
Patients with Multiple SclerosisMS patients (EDSS: 0-5,5)
Receives: Other: Assessment
Healthy groupHealthy individuals without chronic disease
Receives: Other: Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 10 minutes

  2. Vibration sensation

    Duration of vibration sensation will be measured using 128-Hz frequency tuning fork (Elcon1 Medical Instruments, Tuttlingen, Germany).

    Measured: 10 minutes]

  3. 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).

    Measured: 5 minutes

  4. Knee proprioception

    Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).

    Measured: 10 minutes

Secondary outcomes (4)

  1. 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.

    Measured: 5 minutes

  2. attention

    Attention will be evaluated by Trail Making Test.

    Measured: 5 minutes

  3. 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.

    Measured: 10 minutes

  4. 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.

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2020
  2. Study start5 Oct 2020
  3. Primary completion13 May 2022
  4. Study completion13 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
44 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT04548297
Sponsor's protocol ID
2020-122
Status last verified
Aug 2022
First submitted
7 Sep 2020
Last updated
5 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 3734839

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

    PubMed 8449168

  • 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.

    PubMed 20144343

  • 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.

    PubMed 15196521

  • Eldemir K, Ozkul C, Yildirim MS, Eldemir S, Saygili F, Irkec C, Guclu-Gunduz A. Relationship between lower extremity sensation, physical activity, cognition, body awareness, and fatigue in people with multiple sclerosis: a cross-sectional study. Acta Neurol Belg. 2025 Jun;125(3):801-810. doi: 10.1007/s13760-025-02768-1. Epub 2025 Mar 26.

    PubMed 40133734

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Light touch-pressure sensation (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04548297, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.

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