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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD054752 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Medical Rehabilitation Research (NCMRR) | NIH |
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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.
This pilot randomized controlled trial (N=51) includes stroke patients admitted to a sub-acute rehabilitation facility. Subjects will be clinically screened for dysphagia, and randomized into three groups, NMES, sham NMES or usual care -behavioral swallowing therapy arm. Following randomization, all subjects will undergo a video-x-ray (modified barium swallow) of swallowing to confirm the presence of oropharyngeal dysphagia and provide objective data about the nature and degree of dysphagia. All patients will be treated for one hour per day for 3 weeks, and their progress and outcome will be recorded. Participants will be independently evaluated by a blinded assessor at baseline, post treatment and at 3 months following treatment. The primary outcome will be improvement in clinical swallowing ability, oral intake level, and body weight. The results will add to the preliminary data on the effectiveness of this form of swallowing treatment for patients following stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Patients will receive behavioral swallowing therapy comprising combination's of treatment strategies / exercises chosen from an approved hierarchy. This formulation of treatment will be designed and applied by the treating clinician.The treatment will be provided daily for a one-hour over a consecutive 3-week period. |
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| sham NMES | Placebo Comparator | Patients will receive behavioral swallowing therapy comprising combinations of treatment strategies / exercises chosen from an approved hierarchy with the addition of non stimulating electrodes. A faux NMES device will be utilized with an active current display and non stimulating electrodes. The treatment will be provided daily for a one-hour over a consecutive 3-week period. |
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| NMES therapy | Experimental | Patients will receive a protocol of standardized behavioral swallowing intervention combined with NMES. This formulation of treatment will be prescribed from a standard protocol and will be applied daily for one-hour over a consecutive 3-week period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| swallowing therapy | Behavioral | Standardized behavioral swallowing intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of pre-stroke diet | comparison of diet intake | Baseline, 3 weeks (post treatment) and 3 months post |
| Dysphagia-related medical complications | Occurance of chest infection, dehydration or significant weight loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giselle Carnaby-Mann, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siskin Hospital for Physical Rehabilitation | Chattanooga | Tennessee | 37403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18478837 | Background | Carnaby-Mann GD, Crary MA. Adjunctive neuromuscular electrical stimulation for treatment-refractory dysphagia. Ann Otol Rhinol Laryngol. 2008 Apr;117(4):279-87. doi: 10.1177/000348940811700407. | |
| 17576907 | Background | 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. doi: 10.1001/archotol.133.6.564. |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| Baseline,3 weeks ( post treatment) and 3 months post |
| 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) |
| 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 |
| 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 |
| 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 |
| 20434612 | Background | 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. |
| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |