Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing

University of Florida53 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Eligibility

Sex: ALLMin age: 21 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 3 months post treatment

Secondary Outcomes

Recovery of pre-stroke diet

comparison of diet intake

Time frame: Baseline, 3 weeks (post treatment) and 3 months post

Dysphagia-related medical complications

Occurance of chest infection, dehydration or significant weight loss

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: baseline, 3 weeks (post treatment) and at 3-months post treatment

Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes