Dysphagia Clinical Trial
— ANSRSOfficial title:
A Randomized Controlled Trial of NMES vs. Traditional Dysphagia Therapy After Stroke
Verified date | January 2011 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Neuromuscular Electrical stimulation (NMES) for swallowing has recently been proposed for the treatment of dysphagia post stroke and is clinically receiving favor as a treatment modality, in the absence of strong research support. This study aims to investigate the effect of NMES therapy for dysphagia upon recovery of swallowing function following stroke. The study will follow a pilot randomized controlled trial design. Fifty one patients admitted to a sub-acute rehabilitation facility will be clinically screened for dysphagia, and randomized into one of three groups, NMES, sham NMES or usual care -behavioral swallowing therapy arm. All patients will be treated for one hour per day for 3 weeks, and their progress and outcome will be monitored. The results will add to the preliminary data on the effectiveness of this form of swallowing treatment for patients following stroke, and has the potential to enable more efficient allocation of resources to post-acute rehabilitation and thus benefit afforded to stroke patients, and the community.
Status | Completed |
Enrollment | 53 |
Est. completion date | April 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Stroke identified by neurological and radiological examination - Oropharyngeal dysphagia as confirmed by clinical and radiological examination - No prior history of oropharyngeal dysphagia by patient and/or caregiver report - No previous head/neck surgery or trauma that may impact swallowing ability - No other/concomitant neurological disorders (e.g. Parkinson's disease) that would impact oropharyngeal swallowing ability. This does not include post-stroke deficits. - Physician and patient/family agreement to participate. Exclusion Criteria: - Exposed to previous behavioral or NMES swallowing therapy within 6 months of admission - Presence of progressive neurological disorder, such as ALS; Parkinson's or other neurologic disorders within the last 6 months; - History of neurosurgery (either ablative or stimulatory), encephalitis or significant head trauma. - History of a significant medical condition such as heart, liver, or renal disease; history or evidence of malignancy within the past 5 years other than excised basal cell carcinoma. - Because of FDA Warnings, patients with cardiac demand pace makers will be excluded. - Patients with evidence of significant cognitive impairment or dementia as reflected in a Mini-Mental test less than 23 and/or a score of 50% or less on the comprehension quotient on the Western Aphasia Battery. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Siskin Hospital for Physical Rehabilitation | Chattanooga | Tennessee |
Lead Sponsor | Collaborator |
---|---|
University of Florida | National Center for Medical Rehabilitation Research (NCMRR) |
United States,
Carnaby-Mann GD, Crary MA. Adjunctive neuromuscular electrical stimulation for treatment-refractory dysphagia. Ann Otol Rhinol Laryngol. 2008 Apr;117(4):279-87. — View Citation
Carnaby-Mann GD, Crary MA. Examining the evidence on neuromuscular electrical stimulation for swallowing: a meta-analysis. Arch Otolaryngol Head Neck Surg. 2007 Jun;133(6):564-71. — View Citation
Carnaby-Mann GD, Crary MA. McNeill dysphagia therapy program: a case-control study. Arch Phys Med Rehabil. 2010 May;91(5):743-9. doi: 10.1016/j.apmr.2010.01.013. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical response | Mann Assessment of Swallowing Ability (M.A.S.A)and Functional Oral Intake Scale (F.O.I.S) change, without significant weight loss or dysphagia-related complication | 3 weeks post treatment | No |
Primary | Full clinical response | Mann Assessment of Swallowing Ability (M.A.S.A)and Functional Oral Intake Scale (F.O.I.S) change, without significant weight loss or dysphagia-related complication. | 3 months post treatment | No |
Secondary | Recovery of pre-stroke diet | comparison of diet intake | Baseline, 3 weeks (post treatment) and 3 months post | No |
Secondary | Dysphagia-related medical complications | Occurance of chest infection, dehydration or significant weight loss | Baseline,3 weeks ( post treatment) and 3 months post | Yes |
Secondary | Biomechanic evaluation of swallowing function | Modified barium swallow measurement will be used to document changes in swallowing biomechanics associated with change in swallowing following treatment. | Baseline and 3 weeks (post treatment) | No |
Secondary | Functional stroke recovery | Modified Rankin Scale and the Modified Barthel Index will be used to measure functional stroke recovery. | Baseline, 3 weeks (post treatment) and at 3-months post treatment | No |
Secondary | Neurological status/Stroke severity | National Institutes of Health Stroke Scale will be used to measure neurological status change. | baseline, 3 weeks (post treatment) and at the 3-month post treatment | No |
Secondary | Patient perception of swallowing ability | Using a visual analogue scale patients will indicate ability to swallow. | baseline, 3 weeks (post treatment) and at 3-months post treatment | No |
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