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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: Completed Phase 2 study, sponsored by University of Florida.
NCT01279824 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
Interventions
- BEHAVIORAL swallowing therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
What the finished NCT01279824 record still lists
NCT01279824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which swallowing therapy is the first listed.
NCT01279824 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01279824's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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