Clinical trial NCT06381089: Effect Of Robotic Rehabilitation And Vagus Nerve Stimulation In Ischemia Stroke Patients
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Vagus Nerve Stimulation
Robotic Rehabilitation
Autonomic Nervous System
Keywords: Vagus Nerve Stimulation
Transcutaneous
Robotic Rehabilitation
Ischemic Stroke
Superficial EMG
Lead sponsor: Sinop University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: Time Frame: within 10 minutes after intervention
measure: Stroke Specific Quality of Life Scale
timeFrame: Time Frame: within 10 minutes after intervention
measure: 10 Meter Walk Test
timeFrame: Time Frame: within 10 minutes after intervention
measure: Fugl-Meyer Assessment Lower Extremity
timeFrame: Time Frame: within 10 minutes after intervention
measure: Modified Ashworth Scale
timeFrame: Time Frame: within 10 minutes after intervention
measure: Electromyography
timeFrame: Time Frame: within 10 minutes after intervention
measure: Autonomic Nervous System
timeFrame: Time Frame: within 10 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sinop University
name: SEFA HAKTAN HATIK, PhD
role: STUDY_CHAIR
References: