Evaluating the Effects of a Removable Dental Mouthpiece on Symptoms Associated With Parkinson's
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest)
Study Overview
Brief Summary
The investigators are evaluating the immediate effect of a dental mouthpiece on gait and balance among people with Parkinson disease as well as longer-term feasibility use and the effect of the mouthpiece on sleep and quality of life.
Detailed Description
The investigators are conducting a pilot study with participants who have been diagnosed with Parkinson disease recruited from the community. Participants will attend one in-person visit and be custom fitted with a dental mouthpiece. Participants will be asked to wear the mouthpiece as much as possible for one month including while sleeping and during the day, except while eating.
Participants will be asked to return for a second in-person visit to repeat gait and balance (motor) measures.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •have a diagnosis of idiopathic, typical Parkinson Disease according to the United Kingdom Brain Bank Criteria, Hoehn & Yahr stages 1-3;
- •stable Parkinson disease medications for the two weeks prior to baseline visit;
- •be able to walk at least 10 meters at baseline with or without an assistive device;
- •have their own teeth and/or dentures;
- •be willing to try to wear a mouthpiece for one month;
- •are over the age of 30; and
- •provide written or verbal informed consent.
Exclusion Criteria
- •pre-existing medical conditions that would inhibit full participation in the study's tasks;
- •absence of any dentition;
- •cognitive impairments indicated by Mini Mental Status Exam (MMSE) score of <24;
- •freezing of gait which moderately or severely impacts walking; or
- •current use of an oral appliance (e.g., a dental mouthpiece, retainer, or braces).
Arms & Interventions
Dental Mouthpiece
Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans.
Intervention: Dental Mouthpiece (Device)
Outcomes
Primary Outcomes
Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: Baseline in-person visit
Balance will be measured with the Mini-Balance Evaluation Systems Test (Mini-BESTest) with and without the mouthpiece. The assessment includes 14 items each of which is rated on a three-point scale (2: Normal, 1: Moderate, 0: Severe). The 14 item scores are summed for a total score. The range of scores is 0 to 28, and higher scores indicate better balance function.
Changes in Gait Velocity
Time Frame: Baseline in-person visit
Gait velocity will be measured while walking forwards with and without the mouthpiece
Secondary Outcomes
- Changes in Parkinson Disease Questionnaire-39(Baseline and One month)
- Changes in Parkinson Disease Sleep Scale(Baseline and One month)
Investigators
Gammon M Earhart
Director, Program in Physical Therapy
Washington University School of Medicine