The Effects of Two Types of t-DCS Stimulation on Robot-assisted Gait Training in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

The Effects of Transcranial Direct Current Stimulation and Transcutaneous Spinal Direct Current Stimulation on Robot-assisted Gait Training in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06121635
• Other study ID #: 09.2020.1075
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to determine the transcranial direct current stimulation and transcutaneous spinal direct current stimulation in addition to robot-assisted walking training in individuals with Multiple sclerosis; to examine the effects on motor functions against each other and sham application. Secondary aim of this study is to show the relation of these effects with tDCS and ts-DCS through fatigue and quality of life evaluations.

Description:

These study is planned to be carried out in the Cadde Medical Center clinic. The patients who will participate in the study will be determined according to the inclusion criteria among the patients who applied to the Multiple Sclerosis Outpatient Clinic of Istanbul Medeniyet University Göztepe Research Hospital, Department of Neurology. As a result of the power analysis, 36 participants were planned to be included in the study. 20 minutes of non-invasive brain stimulation will be applied to the individuals participating in these study before the 20 minutes robot-assisted walking training (RATG), 3 days a week for 4 weeks. Participants will be divided into 3 groups according to the type of stimulation applied by simple randomization. These groups are 1) anodal tDCS + sham ts-DCS; 2) sham tDCS + cathodal ts-DCS 3) sham tDCS + sham ts-DCS. The same evaluations will be applied to all participants during the study and the evaluations are planned as before and after the intervention. The data collected as a result of the evaluations will be analyzed with SPSS version 22.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: April 30, 2024
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Transcranial Direct Current Stimulation

Intervention

Combination Product:
• Transcutaneous Spinal Direct Current Stimulation and Transcranial Direct Current Stimulation
At the robot-assisted gait training, 20-minute gait training for the patient at an appropriate speed with the Locohelp Woodway device. The aim is to re-teach proper walking, gait cycle timing, and create a near-normal gait pattern through multiple repetitions. Robot-assisted gait training will be performed immediately following the stimulation applied to the patients.
• Sham ts-DCS and sham t-DCS
Sham ts-DCS and sham t-DCS

Locations

Country	Name	City	State
Turkey	Cadde Tip Merkezi	Istanbul	Kadiköy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed 25-Foot Walk (T25-FW)	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.	4 weeks
Primary	Time Up and Go (TUG)	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.	4 weeks
Primary	Multiple Sclerosis Walking Scale-12 (MSWS-12)	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.	4 weeks
Primary	Gait Speed Assessment	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.	4 weeks
Secondary	Fatigue Severity Scale (FSS)	The scale, which includes the experience of fatigue, its causes and its effects on daily life, consists of 9 questions and is a Likert-type scale where each question takes a value between 0 and 7. The highest score reached is 63. A score of 36 or above indicates a high perception of fatigue severity.	4 weeks
Secondary	Fatigue Impact Scale (FIS)	FIS will be used to evaluate the reflection of fatigue on daily activities in patients. This scale evaluates the physical, cognitive and social effects of fatigue in the last month with a total of 40 questions (0 = no problem, 4 = extreme). The total score ranges from 0-160, with higher scores indicating a higher degree of fatigue impact	4 weeks