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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05688878
Other study ID # Qualitative study about TES
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 10, 2022
Est. completion date March 5, 2023

Study information

Verified date January 2023
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine patient opinions and experiences about threshold electrical stimulation treatment applied to stroke patients.


Description:

An exploratory-descriptive qualitative study will be conducted . This study will be conducted with 10 stroke patients receiving threshold electrical stimulation therapy. Threshold electrical stimulation will be applied for 4 weeks, 3 days a week, for one hour. At the end of the 4th week, semi-structured focus group interviews will be held with the patients. . In the semi-structured focus group interviews, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Compared to taking notes by hand; It will be preferable to record the conversation with a voice recorder because it has advantages such as recording all the interviews and allowing the interviewer to focus on the interview. Thematic analysis method will be used in the evaluation of the data.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date March 5, 2023
Est. primary completion date February 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Individuals aged between 18 and 80 years, - Individuals without communication problems, - Individuals who have been diagnosed with stroke Exclusion Criteria: - Uncontrollable arrhythmia and/or hypertension - Presence of advanced sensory deficit - Visual and hearing problems - Not having sufficient communication skills (Mini Mental Test score below 24 points)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Threshold electrical stimulation
Threshold stimulation (EDS) is based on low-intensity (<100 Hz) and long-duration current and is applied with superficial electrodes. Threshold stimulation provides a natural proprioception by depolarizing the sensory and motor nerves without causing any muscle contraction.This treatment will be applied for 4 weeks, 3 days a week, for 1 hour.

Locations

Country Name City State
Turkey Emel Mete Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Semi-structured focus group interviews about patients' Perception of threshold electrical stimulation At the end of the 4th week, semi-structured focus group interviews will be held with the patients. . In the semi-structured focus group interviews, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Thematic analysis method will be used in the evaluation of the data Change from baseline Patients' Perception of Threshold electrical stimulation at week 4
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