Oral Tactile Sensitivity in Stroke Patients

NCT02822391 | Completed

• 1 other identifier: AVC Sens
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastication Disorder; Stroke; No Problem Chewing; Dysphagia

Outcome Measures

Primary Outcomes (1)

• Tactile detection threshold (0.25 - 512 mN) of mechanoreceptors of oral mucosa and lips as assessed with monofilaments of pre-defined thicknesses

  maximum 2 weeks post-stroke

Study Arms (2)

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

Interventions

observation OTHER

Control-group; Stroke-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Stroke-group

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Division of Gerodontology and Removable Prosthodontics, University Clinics of Dental Medicine, University of Geneva

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Martin Schimmel, Prof

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: July 4, 2016
• Study Start: February 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 4, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)