Effect of Transcutaneous Electrical Stimulation on Post-stroke Dysphagic Patients (EETI-01)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 27, 2011 |
| Last Updated Date | January 15, 2013 |
| Start Date ICMJE | January 2012 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01363973 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Effect of Transcutaneous Electrical Stimulation on Post-stroke Dysphagic Patients |
| Official Title ICMJE | Pilot Study to Evaluate the Efficacy and Safety of Transcutaneous Electrical Stimulation on Swallowing in Patients With Oropharyngeal Dysphagia After Stroke |
| Brief Summary | Oropharyngeal dysphagia (OD, swallowing dysfunction) is a major complaint following stroke. Despite its enormous impact on functional capacity, quality of life, and survival, OD is both underestimated and underdiagnosed as a cause of major nutritional and respiratory complications in stroke patients. A recent systematic review on the effects of rehabilitation therapy on OD concluded that although some positive effects were found, the number of studies was small, many of them had methodological problems and there was a need for further research using randomized controlled trials. Transcutaneous electrical stimulation was approved by the FDA as a treatment of dysphagia in June 2001 and is traditionally used to activate pharyngeal muscles through stimulation of peripheral motor nerves (neuromuscular electrical estimulation, NMES). However, their real effectiveness and safety in the treatment of dysphagia is still matter of discussion (Logemann Dysphagia 2007, Ludlow dysphagia 2007) and studies evaluating NMES therapy, present discordant results. On the other hand, in recent years, transcutaneous electrical stimulation is beginning to use as a sensory strategy (Gallas 2010), avoiding muscle contraction during the treatment.Our research strategy includes the assessment of the therapeutic effect of these two main strategies using transcutaneous electrical stimulation on swallow physiology and clinical outcomes of post-stroke dysphagic patients. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Condition ICMJE | Dysphagia |
| Intervention ICMJE | Device: VITALSTIM transcutaneous electrical stimulation |
| Study Arm (s) |
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| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | Not Provided |
| Completion Date | Not Provided |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Spain |
| Administrative Information | |
| NCT Number ICMJE | NCT01363973 |
| Other Study ID Numbers ICMJE | EETI-01 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Pere Clave, Hospital de Mataró |
| Study Sponsor ICMJE | Hospital de Mataró |
| Collaborators ICMJE | Centro de Investigación Biomédica en Red |
| Investigators ICMJE | Not Provided |
| Information Provided By | Hospital de Mataró |
| Verification Date | January 2013 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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