NCT05464225Completed
Colorado Oral Strengthening Device
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Brief summary (registry, in English)
University of Colorado is looking for adults with Parkinson's disease to participate in a research study. The study aims to explore how a novel low technology device can achieve an increase in tongue strength comparable to standard of care exercise using tongue depressors but with the kinematics and simple biofeedback of existing high cost devices. Research has shown that tongue resistance exercises paired with biofeedback have resulted in improved tongue strength to support chewing, control of food and liquid in the mouth, and propulsion of material for a swallow.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 14 Jul 2022
- Start date
- 15 Mar 2023
- Primary completion date
- 10 Mar 2025
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Parkinson disease
- NCT number
- NCT05464225
What you commit to
- Study type: Interventional
- Participants enrolled: 39
- From 15 Mar 2023 to the primary completion date, 10 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Atypical Parkinson's Disease, Parkinson Plus, Lewy Body Dementia, Multiple System Atrophy
- History of head or neck cancer
- History of seizures
- Current or past disorders of the jaw
- Allergy to device materials
Other
- Unwilling to sign the informed consent
Who the study is looking for
- 18 to 89 years old(inclusive)
- Diagnosis of Parkinson's Disease
- Hoen and Yahr stage II-IV
- Signs or symptoms of dysphagia evidenced by an EAT-10 score of 3 or more
Age in the registry: 18 years to 89 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.