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Clinical Trials/NCT06110936
NCT06110936
Completed
Not Applicable

Effects of Transcutaneous Spinal Direct Current Stimulation on Mobility in Cases With Multiple Sclerosis

Istanbul Medeniyet University1 site in 1 country22 target enrollmentNovember 27, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Istanbul Medeniyet University
Enrollment
22
Locations
1
Primary Endpoint
Time Up and Go (TUG)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The primer aim of the study is to examine the effects of the transcutaneous spinal direct current stimulation (ts-DCS) on mobility in addition to the physiotherapy program to individuals with multiple sclerosis. Our secondary aim is to show the relationship of these effects with ts-DCS through fatigue and quality of life evaluations.

Detailed Description

Our study is carried out at Istanbul Cadde Medical Center. The patients who will participate in the study are determined according to the inclusion criteria among the patients who applied to the Multiple Sclerosis Polyclinic of Istanbul Medeniyet University Göztepe Training and Research Hospital, Department of Neurology. Transcutaneous spinal direct current will be applied to the individuals participating in our study in 20-minute sessions, 3 days a week for 2 weeks. According to the type of stimulation applied, participants are divided into two groups: experimental and control groups by simple randomization. While cathodal ts-DAU was applied to the patients in the experimental group; Sham ts-DAU is applied to patients in the control group. The same evaluations will be applied to all participants throughout the study, and the evaluations are applied before and after the intervention. The data collected as a result of the evaluations will be analyzed with SPSS version 22.

Registry
clinicaltrials.gov
Start Date
November 27, 2023
End Date
March 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Medeniyet University
Responsible Party
Principal Investigator
Principal Investigator

Gulser CINBAZ

research assistant

Istanbul Medeniyet University

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with MS and suffering from walking difficulties due to MS
  • EDSS score between 2-6
  • Being over 18 years old

Exclusion Criteria

  • Relapsed within the last two months
  • Changed medication within 45 days
  • Hospitalized in the last three months
  • Had other neurological or musculoskeletal problems
  • Had an obstacle to stimulation (skin problems, metal implants, etc.)
  • Do not want to participate in the study individuals

Outcomes

Primary Outcomes

Time Up and Go (TUG)

Time Frame: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.

It is a performance-based test used to evaluate functional mobility and walking speed. The person is asked to get up from the chair he/she is sitting on without support from his/her arms, walk 3 meters at a safe and normal speed, turn around, walk back, sit on the chair again, and the time is recorded in seconds (sec). The test is started with the patient's feet flat on the floor and arms resting on the armrest of the chair. Three repetitions are made and the best result is recorded.

Gait Speed Assessment

Time Frame: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.

Calculation of walking speed will be done by 2D video analysis method. Kinovea 2D motion analysis software (GPLv2 license, 2019) will be used for analysis. The method has validity and reliability. The videos taken with the cameras placed laterally will be uploaded to the program and the necessary calculations will be made.

Timed 25-Foot Walk (T25-FW)

Time Frame: It will be evaluated twice: immediately before and immediately after 2 weeks treatment.

Timed 25 Foot Walking Test was used for objective evaluation of walking. In T25-FW, which evaluates lower extremity function, the individual is asked to walk 25 steps as quickly and safely as possible (if he/she uses a walking aid, this is done together). The time spent walking is recorded in seconds.

Multiple Sclerosis Walking Scale-12 (MSWS-12)

Time Frame: It will be evaluated twice:immediately before and immediately after 2 weeks treatment.

It is a 12-item rating scale used to assess individuals' perspectives on the impact of their disease on their ability to walk. During the test, patients are asked to rate how much MS affects their mobility, such as standing, walking, running, and climbing stairs, on a 5-point Likert Scale (1=almost not at all, 5=extremely). A high score indicates that walking ability is affected or the patient has difficulty walking. The lowest score can be 12 and the highest score can be 60 from the test.

Secondary Outcomes

  • Fatigue Impact Scale (FIS)(It will be evaluated twice: immediately before and immediately after 2 weeks treatment.)
  • Fatigue Severity Scale (FSS)(It will be evaluated twice: immediately before and immediately after 2 weeks treatment.)

Study Sites (1)

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