Dental Appliance for Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Effects of a Removable Dental Mouthpiece on Symptoms Associated With Parkinson's

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Dental Mouthpiece


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will receive a custom-fitted dental mouthpiece and asked to wear the mouthpiece for one month.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dental Mouthpiece<br>Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans. | Device: Dental Mouthpiece<br>* Participants will complete motor tasks with and without the dental mouthpiece during the in-person baseline visit. They will also be asked to wear the mouthpiece for one month, and complete sleep and quality of life questionnaires before and after wearing the mouthpiece.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Gait Velocity | Gait velocity will be measured while walking forwards with and without the mouthpiece | Baseline in-person visit | 
| Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest) | 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. | Baseline in-person visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Parkinson Disease Sleep Scale | Indicators of sleep quality will be measured before and after wearing mouthpiece for one-month. The visual analog scale has 15 commonly reported symptoms associated with sleep disturbance (e.g., overall quality of nights sleep, restlessness, daytime dozing). Participants mark a cross along a 10 cm line labelled worst to best state. Items are scored by measuring the distance along each line to the intersection with the cross in centimeters. Each item score can range from 0 - symptom severe and always experienced to 10 - symptom-free. The items are summed and the maximum cumulative score is 150 (free of all symptoms). | Baseline and One month | 
| Changes in Parkinson Disease Questionnaire-39 | Quality of life will be measured before and after wearing mouthpiece for one-month. This scale has 39 questions with 5 possible answers (0 = never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always). There are eight dimensions: Mobility questions (q)1-10; Activities of Daily Living q11-16; Emotional well-being q17-22; Stigma q23-26; Social Support q27-29; Cognitive impairment q30-33; Communication q34-36; and Bodily Discomfort q37-39. Dimensions are calculated on a scale of 0 to 100, 0 is no problem at all and 100 is maximum level of a problem. The formula for scoring each dimension: (sum of scores of each question in dimension/4 (max.score per question) x nos. questions in dimension)x100. The formula for a total score (called single index) is sum of dimension scores/8. | Baseline and One month |