Ischemic StrokeERRVNSNCT06381089
Effect Of Robotic Rehabilitation And Vagus Nerve Stimulation In Ischemia Stroke Patients
A study testing Robotic Rehabilitation and Transcutaneous Auricular Vagal Nerve Stimulation in people with Ischemic Stroke and Vagus Nerve Stimulation, run by SEFA HAKTAN HATIK.
Trial summary
This study was conducted in patients with ischemic stroke; This study was conducted to examine the effect of robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation on the patient's functional level and autonomic nervous system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Vagus Nerve Stimulation, Robotic Rehabilitation
- What is being tested?
- Robotic Rehabilitation and Transcutaneous Auricular Vagal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2024to 10 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with ischemic stroke
- Having a stroke for the first time
- Having hemiparesis
- ≤ 6 months after stroke
- Being able to walk with or without support
- Understanding and focusing on Lokomat exercises and being able to do them
Show all 9Show fewer
- Having received walking training with Lokomat in our hospital
- Having signed the voluntary consent form
- Being over 18 years of age
Who cannot join
- Body weight more than 135 kg
- The person's height is more than two meters
- Femur length outside the range of 35-47 cm
- Intolerable leg length differences
- Peripheral nerve injury
- Peripheral neuropathy
Show all 18Show fewer
- Anticholinergic drug use
- Presence of skin lesions
- Spasticity that prevents the locomotive from working
- Having diagnosed psychiatric problems
- Severe contracture in lower extremity muscles
- Not being able to walk before stroke
- Having a history of additional neurological diseases (Parkinson, etc.)
- Unstable cardio-pulmonary disease
- Having orthopedic fractures (lower extremity fractures) and/or joint implants
- Severe osteoporosis
- Uncontrolled hypertension despite medication use
- Lower extremity amputation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Robotic Rehabilitation and Vagus Nerve Stimulation in Addition to Robotic Rehabilitation on the Patient's Functional Level and Autonomic Nervous System in Patients With Ischemic Stroke
This study was conducted in patients with ischemic stroke; This study was conducted to examine the effect of robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation on the patient's functional level and autonomic nervous system.
40 people over the age of 18 participated in the study. They were randomly divided into two groups: robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation. While the robotic rehabilitation group received Lokomat and neurological rehabilitation, the other group received stimulation with the Vagustim device, which is applied non-invasively through the ear, in addition to Lokomat and neurological rehabilitation. Spasticity, autonomic nervous system, walking speed, motor function, quality of life, muscle activity and pain were evaluated in both groups before starting treatment and six weeks after treatment. In the study, significance was evaluated at p<0.05 level.
Read the detailed description
A study group was formed, consisting of individuals who had an ischemic stroke over the age of 18, who complied with the research criteria and who signed the voluntary consent form. Age, gender, height, weight, body mass index, dominant side, affected side and time since stroke of the participants who met the inclusion criteria were recorded and randomly divided into 2 groups.
The groups are; They were divided into Robotic Rehabilitation (RRG) (n=20, 11 women, 9 men) and Transcutaneous Auricular Vagal Nerve Stimulation (VRRG) applied in addition to Robotic Rehabilitation (n=20, 9 women, 11 men) groups.
A 6-week protocol was applied in the study. In addition to the neurological rehabilitation program, robotic rehabilitation was applied to the RRG group 2 days a week. In addition to the neurological rehabilitation program, both robotic rehabilitation and transcutaneous auricular vagal nerve stimulation were applied to the VRRG group 2 days a week. Some evaluations were made by the researcher at two different time periods throughout the study. Evaluation times; T0 (before robotic rehabilitation/vagal nerve stimulation application in addition to robotic rehabilitation), T1 (robotic rehabilitation/after vagal nerve stimulation application applied in addition to robotic rehabilitation). These time periods were planned and carried out immediately before the study and after 6 weeks of treatment.
- Conditions
- Ischemic Stroke, Vagus Nerve Stimulation, Robotic Rehabilitation, Autonomic Nervous System
- Being tested
- Robotic Rehabilitation, Transcutaneous Auricular Vagal Nerve Stimulation
- Keywords
- Vagus Nerve Stimulation, Transcutaneous, Robotic Rehabilitation, Ischemic Stroke, Superficial EMG
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic RehabilitationDevice
Lokomat is an exoskeleton type robotic walking device that can support both extremities symmetrically.
Transcutaneous Auricular Vagal Nerve StimulationDevice
Vagus nerve stimulation is defined as any technique that stimulates the vagus nerve in our body.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Rehabilitation Group (RRG) | Experimental | A 6-week protocol will be applied in the study. In addition to the neurological rehabilitation program, robotic rehabilitation will be applied to the RRG group 2 days a week.
Some evaluations will be made by the researcher at two different time periods throughout the study. These time periods will be planned and carried out immediately before the study and after the 6-week treatment. Receives: Device: Robotic Rehabilitation |
| Vagal Nerve Stimulation With Robotic Rehabilitation Group (VRRG) | Experimental | In addition to the neurological rehabilitation program, the VRRG group will receive both robotic rehabilitation and t-VNS 2 days a week. Some evaluations will be made by the researcher at two different time periods throughout the study. These time periods will be planned and carried out immediately before the study and after the 6-week treatment. Receives: Device: Robotic Rehabilitation; Device: Transcutaneous Auricular Vagal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
Numerical pain scale is used to classify pain from 0 to 10. '0' means no pain and '10' means unbearable pain.
Measured: Time Frame: within 10 minutes after intervention
Stroke Specific Quality of Life Scale
The stroke-specific quality of life scale consists of a total of 49 items in 12 domains. Each item is scored between 1 (strongly agree) and 5 (strongly disagree). The total score is evaluated between 49 and 245 points. A score of 49 indicates the lowest quality of life and 245 indicates the highest quality of life.
Measured: Time Frame: within 10 minutes after intervention
10 Meter Walk Test
During the test, the patient's walking performance is recorded in terms of time between two markers located 10 meters apart. It is used to determine functional mobility and walking speed.
Measured: Time Frame: within 10 minutes after intervention
Fugl-Meyer Assessment Lower Extremity
It is a widely used scale in the evaluation of motor function after stroke. The lower extremity section consists of 17 items and its maximum score is 34 points.
Measured: Time Frame: within 10 minutes after intervention
Modified Ashworth Scale
It is the universally accepted clinical tool used to measure increases in muscle tone.
Measured: Time Frame: within 10 minutes after intervention
Electromyography
It refers to the collective electrical signals during the contraction of muscles connected to the nervous system. EMG devices evaluate and interpret the electrical potential that enables the contraction of voluntary muscles. The EMG device evaluates voluntarily working skeletal muscles. EMG, a muscle examination, monitors and interprets the electrical activity that causes muscles to contract. EMG examinations are defined as a set of tests that include nerve examination as well as examination of muscle activation.
Measured: Time Frame: within 10 minutes after intervention
Autonomic Nervous System
The Polar H10 device is a gold-standard HRV sensor of high sensitivity and accuracy that comes with a wearable chest strap. The device comes with a soft, adjustable sensor that contacts the chest to capture HRV in real time.
Measured: Time Frame: within 10 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start10 May 2024 (estimated)
- Primary completion10 Jul 2024 (estimated)
- Study completion10 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEFA HAKTAN HATIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SEFA HAKTAN HATIK, Sinop University
- Investigators
- SEFA HAKTAN HATIK, PhD, Study chair, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381089
- Sponsor's protocol ID
- VNS004
- Acronym
- ERRVNS
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kizil OD, Ural IH, Hatik SH, Ozden AV, Aydin EB. Effects of transcutaneous auricular vagus nerve stimulation added to robotic rehabilitation in patients with ischemic stroke: a randomized clinical trial. BMC Neurol. 2026 Feb 25;26(1):213. doi: 10.1186/s12883-026-04743-6.
PubMed 41742071
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Robotic Rehabilitation and Vagus Nerve Stimulation in Addition to Robotic Rehabilitation on the Patient's Functional Level and Autonomic Nervous System in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06381089
- Acronym / sponsor ID
- ERRVNS / VNS004
- Conditions
- Ischemic Stroke, Vagus Nerve Stimulation, Robotic Rehabilitation, Autonomic Nervous System
- Keywords
- Vagus Nerve Stimulation, Transcutaneous, Robotic Rehabilitation, Ischemic Stroke, Superficial EMG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SEFA HAKTAN HATIKUniversity, hospital or other
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 10 Aug 2024 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted in patients with ischemic stroke; This study was conducted to examine the effect of robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation on the patient's functional level and autonomic nervous system.
40 people over the age of 18 participated in the study. They were randomly divided into two groups: robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation. While the robotic rehabilitation group received Lokomat and neurological rehabilitation, the other group received stimulation with the Vagustim device, which is applied non-invasively through the ear, in addition to Lokomat and neurological rehabilitation. Spasticity, autonomic nervous system, walking speed, motor function, quality of life, muscle activity and pain were evaluated in both groups before starting treatment and six weeks after treatment. In the study, significance was evaluated at p<0.05 level.
Detailed description
A study group was formed, consisting of individuals who had an ischemic stroke over the age of 18, who complied with the research criteria and who signed the voluntary consent form. Age, gender, height, weight, body mass index, dominant side, affected side and time since stroke of the participants who met the inclusion criteria were recorded and randomly divided into 2 groups.
The groups are; They were divided into Robotic Rehabilitation (RRG) (n=20, 11 women, 9 men) and Transcutaneous Auricular Vagal Nerve Stimulation (VRRG) applied in addition to Robotic Rehabilitation (n=20, 9 women, 11 men) groups.
A 6-week protocol was applied in the study. In addition to the neurological rehabilitation program, robotic rehabilitation was applied to the RRG group 2 days a week. In addition to the neurological rehabilitation program, both robotic rehabilitation and transcutaneous auricular vagal nerve stimulation were applied to the VRRG group 2 days a week. Some evaluations were made by the researcher at two different time periods throughout the study. Evaluation times; T0 (before robotic rehabilitation/vagal nerve stimulation application in addition to robotic rehabilitation), T1 (robotic rehabilitation/after vagal nerve stimulation application applied in addition to robotic rehabilitation). These time periods were planned and carried out immediately before the study and after 6 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Rehabilitation Group (RRG) | Experimental | Device: Robotic RehabilitationA 6-week protocol will be applied in the study. In addition to the neurological rehabilitation program, robotic rehabilitation will be applied to the RRG group 2 days a week. Some evaluations will be made by the researcher at two different time periods throughout the study. These time periods will be planned and carried out immediately before the study and after the 6-week treatment. |
| Vagal Nerve Stimulation With Robotic Rehabilitation Group (VRRG) | Experimental | Device: Robotic Rehabilitation, Device: Transcutaneous Auricular Vagal Nerve StimulationIn addition to the neurological rehabilitation program, the VRRG group will receive both robotic rehabilitation and t-VNS 2 days a week. Some evaluations will be made by the researcher at two different time periods throughout the study. These time periods will be planned and carried out immediately before the study and after the 6-week treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Being diagnosed with ischemic stroke
- Having a stroke for the first time
- Having hemiparesis
- ≤ 6 months after stroke
- Being able to walk with or without support
Key exclusion criteria (18 listed)
- Body weight more than 135 kg
- The person's height is more than two meters
- Femur length outside the range of 35-47 cm
- Intolerable leg length differences
- Peripheral nerve injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic RehabilitationLokomat is an exoskeleton type robotic walking device that can support both extremities symmetrically. | Device | Robotic Rehabilitation Group (RRG), Vagal Nerve Stimulation With Robotic Rehabilitation Group (VRRG) |
| Transcutaneous Auricular Vagal Nerve StimulationVagus nerve stimulation is defined as any technique that stimulates the vagus nerve in our body. | Device | Vagal Nerve Stimulation With Robotic Rehabilitation Group (VRRG) |
Primary outcome
Numerical Pain Rating Scale
Time frame: Time Frame: within 10 minutes after intervention
Numerical pain scale is used to classify pain from 0 to 10. '0' means no pain and '10' means unbearable pain.
Stroke Specific Quality of Life Scale
Time frame: Time Frame: within 10 minutes after intervention
The stroke-specific quality of life scale consists of a total of 49 items in 12 domains. Each item is scored between 1 (strongly agree) and 5 (strongly disagree). The total score is evaluated between 49 and 245 points. A score of 49 indicates the lowest quality of life and 245 indicates the highest quality of life.
10 Meter Walk Test
Time frame: Time Frame: within 10 minutes after intervention
During the test, the patient's walking performance is recorded in terms of time between two markers located 10 meters apart. It is used to determine functional mobility and walking speed.
Fugl-Meyer Assessment Lower Extremity
Time frame: Time Frame: within 10 minutes after intervention
It is a widely used scale in the evaluation of motor function after stroke. The lower extremity section consists of 17 items and its maximum score is 34 points.
Modified Ashworth Scale
Time frame: Time Frame: within 10 minutes after intervention
It is the universally accepted clinical tool used to measure increases in muscle tone.
Electromyography
Time frame: Time Frame: within 10 minutes after intervention
It refers to the collective electrical signals during the contraction of muscles connected to the nervous system. EMG devices evaluate and interpret the electrical potential that enables the contraction of voluntary muscles. The EMG device evaluates voluntarily working skeletal muscles. EMG, a muscle examination, monitors and interprets the electrical activity that causes muscles to contract. EMG examinations are defined as a set of tests that include nerve examination as well as examination of muscle activation.
Autonomic Nervous System
Time frame: Time Frame: within 10 minutes after intervention
The Polar H10 device is a gold-standard HRV sensor of high sensitivity and accuracy that comes with a wearable chest strap. The device comes with a soft, adjustable sensor that contacts the chest to capture HRV in real time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Derived from this study: PubMed 41742071Kizil OD, Ural IH, Hatik SH, Ozden AV, Aydin EB. Effects of transcutaneous auricular vagus nerve stimulation added to robotic rehabilitation in patients with ischemic stroke: a randomized clinical trial. BMC Neurol. 2026 Feb 25;26(1):213. doi: 10.1186/s12883-026-04743-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEFA HAKTAN HATIK, PhD study chair
Sinop University
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Rehabilitation and Transcutaneous Auricular Vagal Nerve Stimulation in people with Ischemic Stroke and Vagus Nerve Stimulation, run by SEFA HAKTAN HATIK.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sefa Haktan HATIK, PhD (00905058761533, haktanhtk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (time frame: Time Frame: within 10 minutes after intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06381089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.