NCT04548297

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

September 7, 2020

Last Update Submit

August 4, 2022

Conditions

Keywords

Multiple Sclerosissensationfatiguephysical activity

Outcome Measures

Primary Outcomes (4)

  • 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

  • Vibration sensation

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

    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

  • 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 Outcomes (4)

  • Fatigue Severity

    5 minutes

  • attention

    5 minutes

  • Physical Activity

    10 minutes

  • Body Awareness

    5 minutes

Study Arms (2)

Patients with Multiple Sclerosis

MS patients (EDSS: 0-5,5)

Other: Assessment

Healthy group

Healthy individuals without chronic disease

Other: Assessment

Interventions

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

Healthy groupPatients with Multiple Sclerosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ambulatory sample

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 3734839BACKGROUND
  • Merchut MP, Gruener G. Quantitative sensory threshold testing in patients with multiple sclerosis. Electromyogr Clin Neurophysiol. 1993 Mar;33(2):119-24.

    PMID: 8449168BACKGROUND
  • 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.

    PMID: 20144343BACKGROUND
  • 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.

    PMID: 15196521BACKGROUND
  • 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.

MeSH Terms

Conditions

Multiple SclerosisFatigueMotor Activity

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Cagla Ozkul

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 14, 2020

Study Start

October 5, 2020

Primary Completion

May 13, 2022

Study Completion

May 13, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations