Clinical Factors Associated With Position Sense in Patients With Multiple Sclerosis

NCT ID: NCT04548297

Last Updated: 2022-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-05

Study Completion Date

2022-05-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with Multiple Sclerosis

MS patients (EDSS: 0-5,5)

Assessment

Intervention Type OTHER

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

Healthy group

Healthy individuals without chronic disease

Assessment

Intervention Type OTHER

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

Interventions

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Assessment

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Cagla Ozkul

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cagla Ozkul

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

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Gazi University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 3734839 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8449168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20144343 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15196521 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40133734 (View on PubMed)

Other Identifiers

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2020-122

Identifier Type: -

Identifier Source: org_study_id

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