NCT04547400

Brief Summary

Balance and gait disturbances are among the most common problems in patients with Multiple Sclerosis (MS). There is evidence of decreased foot sole sensation in MS patients. Studies conducted in healthy individuals have revealed the relationship between balance and foot sole sensation. These studies have demonstrated that sensory feedback from the cutaneous receptors of the foot sole plays an important role in maintaining balance. However, it is not yet known clearly to what extent the sensory impairment seen in MS patients affects balance and gait disorders. The aim of this study is to examine the relationship between lower extremity position sense and foot sole sense with gait and balance in MS patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2020

Completed
8 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 6, 2020

Last Update Submit

August 4, 2022

Conditions

Keywords

Multiple SclerosisGaitBalanceSensation

Outcome Measures

Primary Outcomes (2)

  • Gait

    Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed. Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrica

    5 minutes

  • Balance

    The Modified Sensory Organization Test, which is performed using computerized posturography, measures postural sway in response to 4 different sensory conditions is measured using a force platform.

    10 minutes

Secondary Outcomes (5)

  • Light touch-pressure sensation

    10 minutes

  • Vibration sensation

    10 minutes

  • Two-point discrimination

    10 minutes

  • position sensation of knee joint

    5 minutes

  • Knee proprioception

    10 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 balance, gait, lower extremity position sense, and foot sole sense

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" by a specialist physician Relapse free in the last 3 mounts Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 ) No diagnosis of depression

You may not qualify if:

  • Any cardiovascular, orthopedic, visual, hearing and perception 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 (4)

  • Cattaneo D, Jonsdottir J. Sensory impairments in quiet standing in subjects with multiple sclerosis. Mult Scler. 2009 Jan;15(1):59-67. doi: 10.1177/1352458508096874. Epub 2008 Oct 9.

    PMID: 18845654BACKGROUND
  • Chung LH, Remelius JG, Van Emmerik RE, Kent-Braun JA. Leg power asymmetry and postural control in women with multiple sclerosis. Med Sci Sports Exerc. 2008 Oct;40(10):1717-24. doi: 10.1249/MSS.0b013e31817e32a3.

    PMID: 18799980BACKGROUND
  • 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
  • Roll R, Kavounoudias A, Roll JP. Cutaneous afferents from human plantar sole contribute to body posture awareness. Neuroreport. 2002 Oct 28;13(15):1957-61. doi: 10.1097/00001756-200210280-00025.

    PMID: 12395099BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

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 6, 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