Patient Experiences With Threshold Electrical Stimulation İn Stroke: A Qualitative Study

Stroke Clinical Trial

Official title:

Patient Experiences With Threshold Electrical Stimulation İn Stroke: A Qualitative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688878
• Other study ID #: Qualitative study about TES
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Stroke

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