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

NCT06381089 | Not Yet Recruiting DMC

• 1 other identifier: VNS004
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Ischemic Stroke; Vagus Nerve Stimulation; Robotic Rehabilitation; Autonomic Nervous System

Keywords

Vagus Nerve Stimulation; Transcutaneous; Robotic Rehabilitation; Ischemic Stroke; Superficial EMG

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

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.

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.

Device: Robotic Rehabilitation; Device: Transcutaneous Auricular Vagal Nerve Stimulation

Interventions

Robotic Rehabilitation DEVICE

Lokomat is an exoskeleton type robotic walking device that can support both extremities symmetrically.

Robotic Rehabilitation Group (RRG); Vagal Nerve Stimulation With Robotic Rehabilitation Group (VRRG)

Transcutaneous Auricular Vagal Nerve Stimulation DEVICE

Vagus nerve stimulation is defined as any technique that stimulates the vagus nerve in our body.

Vagal Nerve Stimulation With Robotic Rehabilitation Group (VRRG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SEFA HAKTAN HATIK: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• SEFA HAKTAN HATIK, PhD

  Sinop University

  STUDY CHAIR

Central Study Contacts

Sefa Haktan HATIK, PhD

CONTACT

00905058761533; haktanhtk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: May 10, 2024
• Primary Completion: July 10, 2024
• Study Completion: August 10, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04