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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Şanlıurfa
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Sanliurfa, Şanlıurfa, Turquie (Türkiye), 63200
- Nermin Kart
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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
Autres noms:
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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Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fugl-Meyer Motor Assessment Total Score
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Standardized Mini-Mental State Examination Score
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and Week 8
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Baseline and Week 8
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Systolic Blood Pressure
Délai: Baseline and Week 8
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Baseline and Week 8
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Diastolic Blood Pressure
Délai: Baseline and Week 8
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Baseline and Week 8
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Oxygen Saturation
Délai: Baseline and Week 8
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Baseline and Week 8
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NKnkNK1994.
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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