Dental Appliance for Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Dental Mouthpiece

• Registration Number: NCT04082663
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-09
• Study Start: 2019-09-19
• Primary Completion: 2020-02-10
• Study Completion: 2020-02-10
• Results First Submitted: 2021-01-11
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Results First Posted: 2021-02-24
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dental Mouthpiece	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.

Primary Outcome Measures

Name	Time	Method
Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest)	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	Baseline in-person visit	Gait velocity will be measured while walking forwards with and without the mouthpiece

Secondary Outcome Measures

Name	Time	Method
Changes in Parkinson Disease Questionnaire-39	Baseline and One month	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.
Changes in Parkinson Disease Sleep Scale	Baseline and One month	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).

Trial Locations

Locations (1)

Washington University School of Medicine Program in Physical Therapy; 🇺🇸 Saint Louis, Missouri, United States