Parkinson Disease
Conditions
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.
Interventions
DEVICEDental 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.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will receive a custom-fitted dental mouthpiece and asked to wear the mouthpiece for one month.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Gait Velocity | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Dental Mouthpiece |
|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 9.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Movement Disorders Society - United Parkinson Disease Rating Scale III | 37.25 scores on a scale STANDARD_DEVIATION 8.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 8 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Changes in Gait Velocity
Gait velocity will be measured while walking forwards with and without the mouthpiece
Time frame: Baseline in-person visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dental Mouthpiece | Changes in Gait Velocity | WITHOUT-Mouthpiece | 1.10 m/s | Standard Deviation 0.24 |
| Dental Mouthpiece | Changes in Gait Velocity | WITH-Mouthpiece | 1.15 m/s | Standard Deviation 0.22 |
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.
Time frame: Baseline in-person visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dental Mouthpiece | Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest) | WITHOUT-Mouthpiece | 19.44 score on a scale | Standard Deviation 3.58 |
| Dental Mouthpiece | Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest) | WITH-Mouthpiece | 19.28 score on a scale | Standard Deviation 4.06 |
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.
Time frame: Baseline and One month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dental Mouthpiece | Changes in Parkinson Disease Questionnaire-39 | WITHOUT-Mouthpiece at Baseline | 18.17 score on a scale | Standard Deviation 9.22 |
| Dental Mouthpiece | Changes in Parkinson Disease Questionnaire-39 | One-Month Follow-Up | 17.34 score on a scale | Standard Deviation 11.09 |
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).
Time frame: Baseline and One month
Population: 2 participants missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dental Mouthpiece | Changes in Parkinson Disease Sleep Scale | WITHOUT-Mouthpiece at Baseline | 89.32 score on a scale | Standard Deviation 29.45 |
| Dental Mouthpiece | Changes in Parkinson Disease Sleep Scale | One-Month Follow-Up | 91.68 score on a scale | Standard Deviation 29.94 |