Dental Appliance for Parkinson's Disease (DAPD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04082663|
Recruitment Status : Completed
First Posted : September 9, 2019
Last Update Posted : May 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Dental Mouthpiece||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will receive a custom-fitted dental mouthpiece and asked to wear the mouthpiece for one month.|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Effects of a Removable Dental Mouthpiece on Symptoms Associated With Parkinson's|
|Actual Study Start Date :||September 19, 2019|
|Actual Primary Completion Date :||February 29, 2020|
|Actual Study Completion Date :||February 29, 2020|
Experimental: 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.
Device: Dental Mouthpiece
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.
- Changes in Gait Velocity [ Time Frame: Baseline in-person visit ]Gait velocity will be measured while walking forwards with and without the mouthpiece
- Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest) [ Time Frame: Baseline in-person visit ]Balance will be measured with the Mini-BESTest with and without the mouthpiece
- Changes in Parkinson Disease Sleep Scale [ Time Frame: 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).
- Changes in Parkinson Disease Questionnaire-39 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082663
|United States, Missouri|
|Washington University School of Medicine Program in Physical Therapy|
|Saint Louis, Missouri, United States, 63110|