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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Şanlıurfa
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Sanliurfa, Şanlıurfa, Turquia (Türkiye), 63200
- Nermin Kart
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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
Outros nomes:
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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Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fugl-Meyer Motor Assessment Total Score
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Standardized Mini-Mental State Examination Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline and Week 8
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Baseline and Week 8
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Systolic Blood Pressure
Prazo: Baseline and Week 8
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Baseline and Week 8
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Diastolic Blood Pressure
Prazo: Baseline and Week 8
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Baseline and Week 8
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Oxygen Saturation
Prazo: Baseline and Week 8
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Baseline and Week 8
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NKnkNK1994.
Plano para dados de participantes individuais (IPD)
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