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NCT01279824 · ClinicalTrials.gov registry record · Phase 2

Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing

A Phase 2 study, sponsored by University of Florida.

Completed
Registry status
Phase 2
Development phase
53
Enrollment target

NCT01279824 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 53 participants.

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The verdict

NCT01279824, a Phase 2 study, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 2
Development phase
53 participants
Enrollment target

Study 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.

Interventions

  • BEHAVIORAL swallowing therapy

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2008-04
Est. Completion 2011-04
Phase Phase 2

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT01279824

The ClinicalTrials.gov registry entry for NCT01279824 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which swallowing therapy is the first listed.

NCT01279824 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01279824 about?

NCT01279824 is a clinical study titled "Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing". 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 dysphag...

What is the current status of trial NCT01279824?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2008-04. Estimated completion is 2011-04.

What interventions are being tested in trial NCT01279824?

The interventions under investigation include: swallowing therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT01279824?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.