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Status unknownNCT05688878Updated Jan 18, 2023

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

An interventional study of Threshold electrical stimulation in Stroke, sponsored by Istanbul Medeniyet University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Istanbul Medeniyet University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Aug 2022, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • stroke
  • electric stimulation
  • qualitative research
  • sensory thresholds
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 10 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Istanbul Medeniyet University is the lead sponsor of 188 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Individuals aged between 18 and 80 years,
  • Individuals without communication problems,
  • Individuals who have been diagnosed with stroke

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Experimental group

    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.

    Device: Threshold electrical stimulation

Interventions

  • DeviceThreshold 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Change from baseline Patients' Perception of Threshold electrical stimulation at week 4

07

Study locations

1 of 1 sites recruiting
  • Emel Mete
    Istanbul, Turkey
    • EMEL METE, MSc · Contact · meteemel53@gmail.com · +905376096265
    • Zubeyir SARI, Professor · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05688878
Lead sponsor
Istanbul Medeniyet University
Responsible party
Emel Mete (Research Assistant, Istanbul Medeniyet University) — Principal investigator
First posted
Jan 18, 2023
Start date
Aug 10, 2022
Primary completion
Feb 10, 2023 (estimated)
Completion
Mar 5, 2023 (estimated)
Last update
Jan 18, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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