Back to resultsPatient Experiences With Threshold Electrical Stimulation İn Stroke: A Qualitative Study
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Threshold electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, electric stimulation, qualitative research, sensory thresholds
Eligibility Criteria
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)
Sites / Locations
- Emel MeteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05688878
First Posted
January 9, 2023
Last Updated
January 17, 2023
Sponsor
Istanbul Medeniyet University
1. Study Identification
Unique Protocol Identification Number
NCT05688878
Brief Title
Patient Experiences With Threshold Electrical Stimulation İn Stroke: A Qualitative Study
Official Title
Patient Experiences With Threshold Electrical Stimulation İn Stroke: A Qualitative Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
February 10, 2023 (Anticipated)
Study Completion Date
March 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to determine patient opinions and experiences about threshold electrical stimulation treatment applied to stroke patients.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, electric stimulation, qualitative research, sensory thresholds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Threshold electrical stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Semi-structured focus group interviews about patients' Perception of threshold electrical stimulation
Description
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
Time Frame
Change from baseline Patients' Perception of Threshold electrical stimulation at week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Emel Mete
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EMEL METE, MSc
Phone
+905376096265
Email
meteemel53@gmail.com
First Name & Middle Initial & Last Name & Degree
Zubeyir SARI, Professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Patient Experiences With Threshold Electrical Stimulation İn Stroke: A Qualitative Study
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