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Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing (ANSRS)

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ClinicalTrials.gov Identifier: NCT01279824
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : January 5, 2012
Sponsor:
Collaborator:
National Center for Medical Rehabilitation Research (NCMRR)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE January 7, 2011
First Posted Date  ICMJE January 19, 2011
Last Update Posted Date January 5, 2012
Study Start Date  ICMJE April 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2012)
  • Clinical response [ Time Frame: 3 weeks post treatment ]
    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
  • Full clinical response [ Time Frame: 3 months post treatment ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
  • Clinical response [ Time Frame: At 3 weeks (post treatment) ]
    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
  • Full clinical response [ Time Frame: 3 months post treatment ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
  • Recovery of pre-stroke diet [ Time Frame: Baseline, 3 weeks (post treatment) and 3 months post ]
    comparison of diet intake
  • Dysphagia-related medical complications [ Time Frame: Baseline,3 weeks ( post treatment) and 3 months post ]
    Occurance of chest infection, dehydration or significant weight loss
  • Biomechanic evaluation of swallowing function [ Time Frame: Baseline and 3 weeks (post treatment) ]
    Modified barium swallow measurement will be used to document changes in swallowing biomechanics associated with change in swallowing following treatment.
  • Functional stroke recovery [ Time Frame: Baseline, 3 weeks (post treatment) and at 3-months post treatment ]
    Modified Rankin Scale and the Modified Barthel Index will be used to measure functional stroke recovery.
  • Neurological status/Stroke severity [ Time Frame: baseline, 3 weeks (post treatment) and at the 3-month post treatment ]
    National Institutes of Health Stroke Scale will be used to measure neurological status change.
  • Patient perception of swallowing ability [ Time Frame: baseline, 3 weeks (post treatment) and at 3-months post treatment ]
    Using a visual analogue scale patients will indicate ability to swallow.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing
Official Title  ICMJE A Randomized Controlled Trial of NMES vs. Traditional Dysphagia Therapy After Stroke
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dysphagia
Intervention  ICMJE Behavioral: swallowing therapy
Standardized behavioral swallowing intervention
Study Arms  ICMJE
  • Active Comparator: Usual Care
    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.
    Intervention: Behavioral: swallowing therapy
  • Placebo Comparator: sham NMES
    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.
    Intervention: Behavioral: swallowing therapy
  • Experimental: NMES therapy
    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.
    Intervention: Behavioral: swallowing therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2011)
53
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01279824
Other Study ID Numbers  ICMJE R21HD054752( U.S. NIH Grant/Contract )
R21HD054752 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Center for Medical Rehabilitation Research (NCMRR)
Investigators  ICMJE
Principal Investigator: Giselle Carnaby-Mann, PhD University of Florida
PRS Account University of Florida
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP