Stroke
Conditions
Keywords
dysphagia,endoscopy, electrical stimulation,stroke
Brief summary
The investigators aimed to evaluate effects of combined NMES, FEES and traditional swallowing rehabilitation in stroke patients with moderate-to-severe dysphagia.
Detailed description
Neuromuscular electrical stimulation (NMES)and Fiberoptic endoscopic evaluation of swallowing (FEES) are both promising approaches to enhance swallowing recovery for dysphagic patients. However, there is no literature on the effectiveness of combined application of these modalities in the treatment of patients with poststroke dysphagia. The purpose of this study was to prospectively investigate whether combined NMES, FEES and traditional swallowing rehabilitation can improve swallowing functions in patients with moderate-to-severe dysphagia after stroke.
Interventions
PROCEDUREthe combination group
Patients received 12 sessions of NMES for 1 hour /day, 5 days/week within a period of 2-3 weeks. FEES was done before and after NMES for evaluation and guiding therapy. All patients subsequently received 12 sessions of traditional swallowing rehabilitation (50 minutes/day, 3 days/week) for 4 weeks.
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* age between 20-85 years old * first-time stroke confirmed by computed tomography or magnetic resonance image * dysphagia \> 3 weeks, with preservation of the swallowing reflex * currently on a restricted diet, with a Functional Oral Intake Scale (FOIS) score of 5 or less * Mini-Mental State Examination (MMSE)\> 21 * no obvious mental depression, receptive aphasia or cognitive impairment
Exclusion criteria
* progressive cerebrovascular disease or other neurologic diseases * unstable cardiopulmonary status, serious psychologic disorder or epilepsy; * tumors, extensive surgery or radiotherapy of the head and neck region * cardiac pacemakers * swallowing therapy within 2 months before participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Oral Intake Scale (FOIS) | at 6-month follow-up | The FOIS is a 7-point ordinal scale reflecting the dietary intake of patients with dysphagia. It has adequate reliability and validity and has been used extensively in clinical studies of dysphagia to measure functional oral intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The degree of dysphagia | at 6-month follow-up | The degree of dysphagia was classified from grade 1 to 4 after detailed clinical swallowing evaluation including cranial nerve assessment, observations of swallowing and related movements and swallowing trials using various volumes and consistencies of food |
| swallowing VAS | at 6-month follow-up | Each patient completed a perceptual evaluation of his swallowing ability using a 10-cm visual analog scale (VAS). It was rated by answering a single question: ''How do you qualify your swallowing ability?'' Scores can vary from 0 (no difficulty at all) to 10 (unable to swallow). |
Other
| Measure | Time frame | Description |
|---|---|---|
| global satisfaction to the combination therapy | at 6-month follow-up | Patients were asked to rate the level of global satisfaction to the combination therapy. The rating was based on a 7-point categorical scale weighted from completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied to completely unsatisfied. |
| The occurrence of adverse events or pneumonia | at 6-month follow-up | The occurrence of adverse events or pneumonia was recorded during the study period. |
Countries
Taiwan
Outcome results
None listed