Effect Of Robotic Rehabilitation And Vagus Nerve Stimulation In Ischemia Stroke Patients (ERRVNS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke; Vagus Nerve Stimulation; Autonomic Nervous System; Robotic Rehabilitation
• Intervention / Treatment: Device: Robotic Rehabilitation; Device: Transcutaneous Auricular Vagal Nerve Stimulation

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sefa Haktan HATIK, PhD; Phone Number: 00905058761533; Email: haktanhtk@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Having received walking training with Lokomat in our hospital
• Having signed the voluntary consent form
• Being over 18 years of age

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Rehabilitation Group (RRG); 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.	Device: Robotic Rehabilitation; Lokomat is an exoskeleton type robotic walking device that can support both extremities symmetrically.
Experimental: Vagal Nerve Stimulation With Robotic Rehabilitation Group (VRRG); 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.	Device: Robotic Rehabilitation; Lokomat is an exoskeleton type robotic walking device that can support both extremities symmetrically.; Device: Transcutaneous Auricular Vagal Nerve Stimulation; Vagus nerve stimulation is defined as any technique that stimulates the vagus nerve in our body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Time Frame: within 10 minutes after intervention
Modified Ashworth Scale	It is the universally accepted clinical tool used to measure increases in muscle tone.	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.	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.	Time Frame: within 10 minutes after intervention

Collaborators and Investigators

• Sponsor: SEFA HAKTAN HATIK
• Investigators: Study Chair: SEFA HAKTAN HATIK, PhD, Sinop University

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2024
• Primary Completion (Estimated): July 10, 2024
• Study Completion (Estimated): August 10, 2024

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Vagus Nerve Stimulation; Transcutaneous; Robotic Rehabilitation; Superficial EMG
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: VNS004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No