NCT05688878

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

January 9, 2023

Last Update Submit

January 17, 2023

Conditions

Stroke

Keywords

strokeelectric stimulationqualitative researchsensory thresholds

Outcome Measures

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

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

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Threshold electrical stimulationDEVICE

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.

Experimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emel Mete

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 18, 2023

Study Start

August 10, 2022

Primary Completion

February 10, 2023

Study Completion

March 5, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

TU(1)