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Oral Tactile Sensitivity in Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02822391
Recruitment Status : Completed
First Posted : July 4, 2016
Last Update Posted : July 4, 2016
Sponsor:
Information provided by (Responsible Party):
University of Bern

Brief Summary:

Orofacial impairment following stroke frequently involves a reduced chewing performance and dysphagia. This study investigated the sensitivity of oral tissues following stroke and its potential impact on chewing efficiency.

The following two Null-hypotheses (H0) were tested:

i. Post-stroke patients do not show a reduced intra-oral sensitivity compared to a healthy controls.

ii. Intra-oral sensitivity is not correlated to chewing efficiency.


Condition or disease Intervention/treatment
Mastication Disorder Stroke No Problem Chewing Dysphagia Other: observation

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Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Tactile Sensitivity of the Oral Tissues and Chewing Efficiency Are Impaired in Stroke Patients
Study Start Date : February 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
Stroke-group
Screened and recruited from the Division of Neurorehabilitation, Department of Clinical Neurosciences, University Hospital and University of Geneva, Geneva, Switzerland by a senior consultant neurologist (BL). Patients were included if they were hospitalized for stroke rehabilitation, were able to undergo psychophysical testing and presented with a facial impairment according to the House-Brackmann criteria ≥2 15. They were excluded if they presented with acute pain in the oro-facial sphere (nominal question) or an additional neuro-muscular disease.
Other: observation
Control-group
Similar to stroke group in regard to age, gender and dental state. no stroke
Other: observation



Primary Outcome Measures :
  1. Tactile detection threshold (0.25 - 512 mN) of mechanoreceptors of oral mucosa and lips as assessed with monofilaments of pre-defined thicknesses [ Time Frame: maximum 2 weeks post-stroke ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Stroke-group
Criteria

Inclusion Criteria:

  • Written informed consent
  • Hospitalized for stroke rehabilitation
  • Able to undergo psychophysical testing
  • Presented with a facial impairment according to the House-Brackmann criteria ≥2

Exclusion Criteria:

  • Presented with acute pain in the oro-facial sphere (nominal question)
  • Additional neuro-muscular disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822391


Locations
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Switzerland
Division of Gerodontology and Removable Prosthodontics, University Clinics of Dental Medicine, University of Geneva
Geneva, Switzerland, 1205
Sponsors and Collaborators
University of Bern
Investigators
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Principal Investigator: Martin Schimmel, Prof University of Bern
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT02822391    
Other Study ID Numbers: AVC Sens
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases