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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01279824
Other study ID # R21HD054752
Secondary ID R21HD054752
Status Completed
Phase Phase 2/Phase 3
First received January 7, 2011
Last updated January 4, 2012
Start date April 2008
Est. completion date April 2011

Study information

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

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
swallowing therapy
Standardized behavioral swallowing intervention

Locations

Country Name City State
United States Siskin Hospital for Physical Rehabilitation Chattanooga Tennessee

Sponsors (2)

Lead Sponsor Collaborator
University of Florida National Center for Medical Rehabilitation Research (NCMRR)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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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