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

This study has been completed.
Sponsor:
Collaborator:
National Center for Medical Rehabilitation Research (NCMRR)
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01279824
First received: January 7, 2011
Last updated: January 4, 2012
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Dysphagia
Behavioral: swallowing therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of NMES vs. Traditional Dysphagia Therapy After Stroke

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Clinical response [ Time Frame: 3 weeks post treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Recovery of pre-stroke diet [ Time Frame: Baseline, 3 weeks (post treatment) and 3 months post ] [ Designated as safety issue: No ]
    comparison of diet intake

  • Dysphagia-related medical complications [ Time Frame: Baseline,3 weeks ( post treatment) and 3 months post ] [ Designated as safety issue: Yes ]
    Occurance of chest infection, dehydration or significant weight loss

  • Biomechanic evaluation of swallowing function [ Time Frame: Baseline and 3 weeks (post treatment) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Using a visual analogue scale patients will indicate ability to swallow.


Enrollment: 53
Study Start Date: April 2008
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: swallowing therapy
Standardized behavioral swallowing intervention
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.
Behavioral: swallowing therapy
Standardized behavioral swallowing intervention
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.
Behavioral: swallowing therapy
Standardized behavioral swallowing intervention

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.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279824

Locations
United States, Tennessee
Siskin Hospital for Physical Rehabilitation
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
University of Florida
National Center for Medical Rehabilitation Research (NCMRR)
Investigators
Principal Investigator: Giselle Carnaby-Mann, PhD University of Florida
  More Information

Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01279824     History of Changes
Other Study ID Numbers: R21 HD054752, R21 HD054752
Study First Received: January 7, 2011
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
swallowing, treatment, stroke,rehabilitation

Additional relevant MeSH terms:
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Otorhinolaryngologic Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on November 20, 2014