NCT05779293

Brief Summary

Stroke is still one of the top causes of death and adult-onset disability in the world. Despite physiotherapy and rehabilitation, a sizable percentage of chronic stroke patients are permanently disabled. These neurological deficiencies include cognitive impairment, sensory impairment, loss of coordination, spasticity, dysphasia, dysphagia, visual field dysfunction, and weakness.

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
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2023

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

First Submitted

Initial submission to the registry

March 9, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

March 9, 2023

Last Update Submit

March 23, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (6)

  • Brunstrom Hemiplegia Recovery Stages

    Brunnstrom Score; It was used to evaluate motor recovery in the upper extremity, hand, and lower extremity, as well as to indicate which motor level the patient was at. Brunnstrom is a 6-digit scale containing progressively improving movement patterns for each area used

    4 weeks

  • Timed Get Up and Go Test

    Getting out of the chair is in the form of walking back and forth 3 meters and sitting on the chair again. The aim is to measure the individual's time to complete this process. A high score indicates a high disability score.

    4 weeks

  • Berg Balance Scale

    Berg Balance Scale is a scale developed to measure balance performance in geriatric people or geriatric patients. It is frequently used in clinical studies to evaluate postural control and to predict fall risk.scoring is between 0-51 points, with a high score indicating good balance.

    4 weeks

  • The Modified Ashworth Scale,

    The Modified Ashworth Scale, developed by Ashworth, is an international method used to evaluate the resistance encountered during passive muscle stretching in muscles with spasticity, which were later modified. It is rated at 6 levels from 0 to 4 to assess muscle tone. The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extensio

    4 weeks

  • Montreal Cognitive Assessment Scale

    It was developed as a rapid screening test for mild cognitive impairment. These are; attention and concentration, executive functions, memory, language, visual construction skills, abstract thinking, calculation and orientation. Montreal Cognitive Assessment Scale scores range between 0 and 30. It is between 0-30 points. A score of 21 and above is considered normal.A high score indicates a good cognitive level.

    4 weeks

  • Standardized Mini Mental State Test

    The Mini Mental Test is a test that can be applied in outpatient clinic conditions or at the bedside in a period of 10 minutes by physicians, nurses and psychologists who have received a short training. It consists of eleven items gathered under five main headings as orientation, recording memory, attention and calculation, recall and language, and is evaluated out of a total score of 30.Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.

    4 weeks

Secondary Outcomes (1)

  • Stroop test

    4 weeks

Study Arms (2)

non-invasive auricular vagus nerve stimulation

EXPERIMENTAL

non-invasive auricular vagus nerve stimulation + Neuromuscular Electrical Stimulation (NMES) exercise under the supervision of a physiotherapist

Device: Non-invasive auricular vagus nerve stimulation

Conventional physical therapy

ACTIVE COMPARATOR

NMES exercise under the supervision of a physiotherapist

Other: Conventional therapy

Interventions

Non-invasive auricular vagus nerve stimulationDEVICE

The only cutaneous nerve of the N. vagus, ramus auricularis, receives sensation from the posterior surface of the auricle, the posterior part of the external auditory canal and the adjacent part of the eardrum. Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid. This device non-invasively stimulates the auricular branch of the vagus nerve without any action. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased. The application will take 30 minutes three days a week for four weeks.

non-invasive auricular vagus nerve stimulation
Conventional therapyOTHER

Conventional approaches are approaches that cover range of motion, strength, balance and ambulation training, continuing from passive to resistant exercises. Neuromuscular electrical stimulation; It is applied to reduce pain, prevent spasticity and strengthen muscles. This newly formed type I fiber functionally shows an increase in resistance to fatigue and a decrease in maximum contraction velocity. The application will take 30 minutes three days a week for four weeks.

Conventional physical therapy

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be between the ages of 18-80.
  • Having been diagnosed with a stroke by a neurologist.
  • Speech disorder after a cerebrovascular accident to be.
  • To volunteer to participate in the study.

You may not qualify if:

  • Being mentally affected (Mini-Mental Test Score \<24).
  • Having other neurological diseases other than stroke.
  • Concomitant symptoms that prevent individuals from participating in the study (Having undergone amputation surgery, having cardiac arrhythmias be etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol hospital

Istanbul, 34070, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Baig SS, Kamarova M, Ali A, Su L, Dawson J, Redgrave JN, Majid A. Transcutaneous vagus nerve stimulation (tVNS) in stroke: the evidence, challenges and future directions. Auton Neurosci. 2022 Jan;237:102909. doi: 10.1016/j.autneu.2021.102909. Epub 2021 Nov 14.

    PMID: 34861612BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

HAZAL genç, PhD

CONTACT

05413204291hazaloksuz@gmail.com

gamze demircioğlu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Evaluation and treatment will be carried out by different physiotherapists. In this way, it is aimed to provide an objective evaluation
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist PhD

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 22, 2023

Study Start

March 9, 2023

Primary Completion

June 5, 2023

Study Completion

October 5, 2023

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

TU(1)