Effect Of Robotic Rehabilitation And Vagus Nerve Stimulation In Ischemia Stroke Patients
NCT ID: NCT06381089
Last Updated: 2024-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-05-10
2024-08-10
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Robotic Rehabilitation
Lokomat is an exoskeleton type robotic walking device that can support both extremities symmetrically.
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.
Robotic Rehabilitation
Lokomat is an exoskeleton type robotic walking device that can support both extremities symmetrically.
Transcutaneous Auricular Vagal Nerve Stimulation
Vagus nerve stimulation is defined as any technique that stimulates the vagus nerve in our body.
Interventions
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Robotic Rehabilitation
Lokomat is an exoskeleton type robotic walking device that can support both extremities symmetrically.
Transcutaneous Auricular Vagal Nerve Stimulation
Vagus nerve stimulation is defined as any technique that stimulates the vagus nerve in our body.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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SEFA HAKTAN HATIK
OTHER
Responsible Party
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SEFA HAKTAN HATIK
Assistant Professor
Principal Investigators
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SEFA HAKTAN HATIK, PhD
Role: STUDY_CHAIR
Sinop University
Central Contacts
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Other Identifiers
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VNS004
Identifier Type: -
Identifier Source: org_study_id
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