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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dental Mouthpiece | Experimental | Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Mouthpiece | Device | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gammon M Earhart, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine Program in Physical Therapy | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27977521 | Background | Lane H, Rose LE, Woodbrey M, Arghavani D, Lawrence M, Cavanaugh JT. Exploring the Effects of Using an Oral Appliance to Reduce Movement Dysfunction in an Individual With Parkinson Disease: A Single-Subject Design Study. J Neurol Phys Ther. 2017 Jan;41(1):52-58. doi: 10.1097/NPT.0000000000000160. | |
| 26044345 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Gait Velocity | Gait velocity will be measured while walking forwards with and without the mouthpiece | Posted | Mean | Standard Deviation | m/s | Baseline in-person visit |
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One month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritation/Discomfort from mouthpiece | Product Issues | Non-systematic Assessment | Participants noted that the mouthpiece caused mouth irritation/discomfort. |
High number of withdrawals leading to smaller than expected number of participants to analyze outcomes over the one month period.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gammon Earhart | Washington University School of Medicine | 314-286-1407 | earhartg@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2019 | Jan 11, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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All participants will receive a custom-fitted dental mouthpiece and asked to wear the mouthpiece for one month.
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|
| 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 |
| Potter K, Brandfass K. The Mini-Balance Evaluation Systems Test (Mini-BESTest). J Physiother. 2015 Oct;61(4):225. doi: 10.1016/j.jphys.2015.04.002. Epub 2015 Jun 1. No abstract available. |
| 9351479 | Background | Jenkinson C, Fitzpatrick R, Peto V, Greenhall R, Hyman N. The Parkinson's Disease Questionnaire (PDQ-39): development and validation of a Parkinson's disease summary index score. Age Ageing. 1997 Sep;26(5):353-7. doi: 10.1093/ageing/26.5.353. |
| 21312275 | Background | Trenkwalder C, Kohnen R, Hogl B, Metta V, Sixel-Doring F, Frauscher B, Hulsmann J, Martinez-Martin P, Chaudhuri KR. Parkinson's disease sleep scale--validation of the revised version PDSS-2. Mov Disord. 2011 Mar;26(4):644-52. doi: 10.1002/mds.23476. Epub 2011 Feb 10. |
| 23526322 | Background | Moeller DR. Evaluation of a Removable Intraoral Soft Stabilization Splint for the Reduction of Headaches and Nightmares in Military PTSD Patients: A Large Case Series. J Spec Oper Med. 2013 Spring;13(1):49-54. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Movement Disorders Society - United Parkinson Disease Rating Scale III | Thirty-three items on the Movement Disorders Society - United Parkinson Disease Rating Scale Part III Motor Examination are rated using five response options of 0: Normal, 1: Slight, 2: Mild, 3: Moderate, 4: Severe. The items are summed for a total score indicating overall severity of motor signs and symptoms of Parkinson's disease. The minimum score is 0 reflecting normal motor functioning and the maximum score of 132 reflecting severe motor impairment. In other words, higher scores represent worse outcomes. | Mean | Standard Deviation | scores on a scale |
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| Participants |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline in-person visit |
|
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| Secondary | 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). | 2 participants missing data | Posted | Mean | Standard Deviation | score on a scale | Baseline and One month |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and One month |
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| 0 |
| 20 |
| 0 |
| 20 |
| 8 |
| 20 |
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| Loose filling replaced | Surgical and medical procedures | Non-systematic Assessment | Loose filling replaced by participant's dentist; unrelated to mouthpiece |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |