The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia
- Conditions
- Swallowing DisorderDysphagiaStroke, ComplicationCerebrovascular AccidentStroke
- Registration Number
- NCT04421937
- Lead Sponsor
- Istanbul University
- Brief Summary
In our study, our aim is to evaluate the effect of neuromuscular electrical stimulation added to traditional dysphagia therapy in stroke patients with dysphagia, on functional oral intake status, dysphagia-related symptoms, quality of life, and complications related to dysphagia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- After the first week after a stroke, detecting dysphagia by using bedside water assessment test
- Lesion location is shown by MRI or CT
- Unsupported sitting balance
- The score of Mini-mental state examination test (MMSE) 20 and above
- Over 18 years old
- Global aphasia or cognitive disorders that may affect the understanding of the instructions
- Patients with major medical problems that may affect participation
- Tracheostomy presence
- Previous neck surgery
- To have received radiotherapy in the head or neck area
- Presence of a cardiac pacemaker or a history of epilepsy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Functional Oral Intake Scale (FOIS) before intervention, immediately after intervention, 3 months after the intervention Functional Oral Intake Scale (FOIS) is a scale that shows the functional oral intake of patients with dysphagia. FOIS used for evaluation is a two part scale consisting of 7 levels. It is used to show whether the individual is dependent on the feeding tube and the level of oral intake. On this scale, 7 shows the best and 1 shows the worst functional oral intake. The change in FOIS will be our primary outcome measure in our research. It has been evaluated as an appropriate tool to demonstrate the change in functional oral intake in stroke patients. It is suitable as an independent measure of functional oral intake in prospective studies of stroke-related dysphagia.
- Secondary Outcome Measures
Name Time Method Change in Eating Assessment Tool-10 (EAT-10) Score before intervention, immediately after intervention, 3 months after the intervention Eating Assessment Tool-10 (EAT-10) is used to assess participants' dysphagia symptoms, symptom severity, and risk of oropharyngeal dysphagia. This scale is a scale of 10 questions that the patient himself answers, which questions the symptoms of dysphagia. The answer points for each question range from 0 (no problem) to 4 (serious problem). If EAT-10 score is ≥3, it is considered as "risk of oropharyngeal dysphagia". It is a useful tool to evaluate the severity of dysphagia symptom in the clinic, to monitor the progression and effectiveness of the disease.
Change in Swallowing-related Quality of Life (SWAL-QOL) Score before intervention, immediately after intervention, 3 months after the intervention Swallowing-related quality of life scale (SWAL-QOL) is used to evaluate the effect of swallowing disorders on quality of life. It was created to evaluate the quality of life of patients with oropharyngeal dysphagia. It includes a total of 44 questions under eating disorder, eating time, eating desire, food selection, communication, anxiety, mental health, social functionality, fatigue, and sleep subgroups. Each question is evaluated with a score ranging from 1 (worst) to 5 (best). The subgroup scores of the scale and the total score of the scale can be used to assess the change in patients.
Change in Voice-Related Quality of Life (V-RQOL) Score before intervention, immediately after intervention, 3 months after the intervention This ten-item scale is a scale designed for adult populations with voice disorders to measure both social-emotional and physical-functional aspects of voice problems. The answer points for each question range from 1 (few problems) to 5 (serious problems). A total score change on this scale will be used to evaluate patients.
Change in Visual Analog Scale (VAS) before intervention, immediately after intervention, 3 months after the intervention Patients' difficulty in swallowing will be questioned using the Visual Analogue Scale (VAS). On a scale of ten centimeters, patients will be asked to mark the appropriate level of dysphagia 0: No dysphagia, 10: Very severe dysphagia.
Change in Laryngostroboscopy Examination before intervention, immediately after intervention In the Istanbul Faculty of Medicine Otorhinolaryngology Diseases Clinic, evaluations will be made by the Ear Nose Throat Specialist. Whether there is vocal cord paresis and paralysis and whether glottic patency is evaluated in the laryngostroboscopic examination.
Change in Fiberoptic Endoscopic Evaluation of Swallowing (FEES) before intervention, immediately after intervention Fiberoptic endoscopic swallowing assessment will be performed by the otolaryngologist doctor before and immediately after the treatment. In the fiberoptic endoscopic swallowing assessment, the condition of the patient according to the penetration aspiration scale will be checked. Grade 1 represents the best and grade 7 the worst on the penetration aspiration scale.
Trial Locations
- Locations (1)
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
🇹🇷Istanbul, Fatih, Turkey