Vagal Stimulation in Individuals With Stroke
Effects of Manual Vagus Nerve Stimulation on Motor, Autonomic, and Cognitive Functions in Individuals With Stroke
The aim of this study is to investigate the effects of manual vagus nerve stimulation (VNS) on motor, autonomic, and cognitive functions in individuals with chronic stroke. Additionally, researchers will assess the safety of this treatment. The primary research questions that this study aims to address are as follows:
Does manual vagus nerve stimulation improve motor function in individuals with chronic stroke? Does manual vagus nerve stimulation influence autonomic functions in individuals with chronic stroke? Does manual vagus nerve stimulation accelerate cognitive recovery in individuals with chronic stroke? Researchers will compare the effects of manual vagus nerve stimulation with a standard rehabilitation program.
Participants in the experimental group will receive manual vagus nerve stimulation three times a week for eight weeks, in addition to the standard rehabilitation program. Participants in the control group will receive only the standard rehabilitation program.
Each participant will:
Attend clinical assessments and evaluation tests. Have their motor skills, autonomic function, and cognitive status recorded at the beginning of the treatment and at the end of the eight-week intervention period.
This study will contribute to a better understanding of the potential of manual vagus nerve stimulation as a novel therapeutic approach for individuals with stroke.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Şanlıurfa
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Sanliurfa, Şanlıurfa, Turecko (Türkiye), 63200
- Nermin Kart
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Having experienced an ischemic or hemorrhagic stroke
- Diagnosed with stroke at least six months prior
- No history of multiple stroke episodes
- No communication impairments
- Ability to read and write
Exclusion Criteria:
- Presence of hearing loss
- Receiving additional treatment alongside rehabilitation
- Cardiopulmonary disease
- Gastrointestinal disease
- History of a recent trauma
- Presence of neurological disorders other than stroke
- Presence of psychological disorders
- History of a condition that could have previously affected cognitive function
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: study group
The participants in the study group consist of individuals with chronic stroke.
In addition to the standard rehabilitation program, these individuals will receive manual vagus nerve stimulation (mVNS) as part of the intervention.
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Manual Vagus Nerve Stimulation (mVNS) Manual vagus nerve stimulation (mVNS) is a non-invasive, accessible, and cost-effective alternative to electrical vagus nerve stimulation (VNS). Unlike invasive methods, mVNS targets key vagal pathways through manual techniques that aim to modulate autonomic function, enhance neuroplasticity, and promote recovery. This study applies mVNS twice a week for eight weeks, using the following techniques: Suboccipital Inhibition Technique: Both hands are placed under the occiput, applying deep, gliding, and progressive pressure for 10 minutes to relax suboccipital muscles. Fourth Ventricle Technique: Hands are positioned under the occiput, applying cephalic traction for 10 minutes to aid autonomic nervous system balance. Diaphragm Release: Hands are placed bilaterally on the anterior lower ribs, applying gentle traction during inspiration and pressure during expiration. Carotid Sinus Massage: Mechanical pressure is applied above the thyroid cartilag
Ostatní jména:
Passive and Active Joint Movements: Applied to maintain joint range of motion and prevent contractures. Muscle Strengthening Exercises: Isometric, isotonic, and resistance exercises are used to strengthen weakened muscle groups. Balance and Gait Training: Supported by proprioceptive exercises and weight-shifting techniques. |
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Aktivní komparátor: control group
Individuals in this group, consisting of chronic stroke patients, will receive only the standard rehabilitation program without any additional interventions.
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Passive and Active Joint Movements: Applied to maintain joint range of motion and prevent contractures. Muscle Strengthening Exercises: Isometric, isotonic, and resistance exercises are used to strengthen weakened muscle groups. Balance and Gait Training: Supported by proprioceptive exercises and weight-shifting techniques. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Fugl-Meyer Motor Assessment Total Score
Časové okno: Baseline and Week 8
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Motor function will be assessed using the Fugl-Meyer Motor Assessment (FMA).
The scale evaluates motor recovery of the upper and lower extremities in individuals with stroke.
Total scores range from 0 to 100, with higher scores indicating better motor function.
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Baseline and Week 8
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Standardized Mini-Mental State Examination Score
Časové okno: Baseline and Week 8
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Cognitive function will be assessed using the Standardized Mini-Mental State Examination (SMMSE).
The total score ranges from 0 to 30, with higher scores indicating better cognitive function.
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Baseline and Week 8
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4-Meter Walk Test Speed
Časové okno: Baseline and Week 8
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Walking speed will be assessed using the 4-Meter Walk Test (4MWT).
Participants will be instructed to walk a distance of 4 meters, and walking speed will be calculated in meters per second (m/s).
Higher walking speed values indicate better walking performance.
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Baseline and Week 8
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Constipation Severity Scale Score
Časové okno: Baseline and Week 8
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Constipation severity will be assessed using the Constipation Severity Scale (CSS).
The total score ranges from 0 to 73, with higher scores indicating greater severity of constipation symptoms and therefore a worse outcome.
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Baseline and Week 8
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Heart Rate
Časové okno: Baseline and Week 8
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Baseline and Week 8
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Systolic Blood Pressure
Časové okno: Baseline and Week 8
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Baseline and Week 8
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Diastolic Blood Pressure
Časové okno: Baseline and Week 8
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Baseline and Week 8
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Oxygen Saturation
Časové okno: Baseline and Week 8
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Baseline and Week 8
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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