Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
Not provided
Not provided
The purpose of this research study is to test the safety, tolerability, and the effect of vibration (delivered by an experimental device called PDVibe2) on freezing of gait (FOG) in persons with Parkinson's disease (PD). The PDVibe2 was developed by Resonate Forward, LLC (RF). This PDVibe2 was designed to administer vibration therapy to the wearer to improve gait and balance in persons with PD while wearing the device.
Enrolled patients with Parkinson's disease, Hoehn and Yahr Stage 2, will be randomized to receive either vibration or no vibration and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of two days followed by a washout period of 2 weeks. Each treatment period will consist of four treatments within 2 days, no more than 2 sessions in one day.
Patients will participate in an additional day for screening and another for follow-up (6 days total). All visits will occur at the Virginia Commonwealth University Parkinson's Movement and Disorders Center in Richmond, VA. Participants will be asked to walk for a brief period of time while wearing the PDVibe2. The PDVibe2 will provide vibration therapy and study staff will measure the number of "freezes" before, during and after therapy. Participants will be asked to provide feedback on the device, the therapy session, and how they are feeling.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibration first then no vibration | Experimental | A session with PDVibe2 vibration turned on first, followed by (after a 2 week washout period) a session with PDVibe2 vibration turned off. The two arms both get a session with the PDVibe2 vibration turned on and turned off, but the order is reversed depending on the arm. |
|
| No vibration first then vibration | Experimental | A session with PDVibe2 vibration turned off first, followed by (after a 2 week washout period) a session with PDVibe2 vibration turned on. The two arms both get a session with the PDVibe2 vibration turned on and turned off, but the order is reversed depending on the arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibration Session | Device | The PDVibe2 is owned by Resonate Forward, LLC and will be loaned to Virginia Commonwealth University (VCU) for this project. The device is non-invasive, lightweight, untethered, contains a rechargeable battery, and is worn on both feet and ankles. PDVibe2 delivers vibration when activated by an easy to access switch on the device or by remote. The internal circuitry has been miniaturized, is encased in a small box, and is attached to the ankle using a soft flexible band. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Ambulation Profile (FAP) Score | The Functional Ambulation Profile (FAP) score is the gold standard for spatiotemporal gait parameter analysis. For this study, it will be mean calculated by participants walking on the Zeno walkway, which will measure the patient's physical measurements, step length, step time and degree of symmetry., dynamic base of support and the use of ambulatory aids are factored into the score. The Zeno instrumented walkway (PKMAS) is a 20-foot computerized walkway containing sensor pads. A full FAP (Functional Ambulation Profile) score is calculated by deducting points from a maximum score of 100 and the minimum is a 0, with points being subtracted based on deviations from normal gait patterns observed during a self-selected velocity walking trial; essentially, a higher score (closer to 100) indicates closer to normal gait function while a lower score (closer to 0) represents greater gait impairments. No subscales. This is reported as the mean of the two scores for each session aggregated. | Throughout study completion, from 9 to 34 days. |
| Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS),will be used to assess the total burden of motor Parkinson Disease (PD) symptoms and impact on activities of daily living. There are four sections to this scale and all sections use a scale of 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe)lower scores are better and indicate less disability. Part II: 13 items about Activities of Daily Living, score range 0-52. Part III: 18 items PD motor signs, score range is 0-72, Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). Part IV: 6 items, assesses dyskinesia (excessive motion) and motor fluctuations (medication is working or not), range is 0-24. Parts II-IV total scores. This is reported as the mean of the scores for each session aggregated. The smaller the overall number (closer to 0), the less disability and the greater the number (closer to 148) the greater the disability. | Throughout study completion, from 9 to 34 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go (TUG) Test | The Timed Up and Go (TUG) Test is a one-item performance test. The participant starts by sitting in a chair, then stand up, walk 3 meters, turn around, walk back, and sit down. Participants are timed in seconds. TUG is used to identify/screen elderly individuals who are prone to falls. Lower times/measured in seconds is better. The Timed Up and Go (TUG) test is scored based on the time it takes to complete the test, in seconds: < 10 seconds: Normal < 20 seconds: Good mobility, can walk outside alone, no walking aid needed < 30 seconds: Walking and balance problems, cannot walk outside alone, walking aid needed So less than 10 seconds would be normal and 30 seconds or more may indicate a higher risk of falling. This is reported as the mean of the scores for each session aggregated. |
Not provided
Inclusion criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ingrid Pretzer-Aboff, PhD, RN | Virginia Commonwealth University | Principal Investigator |
| Leslie Cloud, MD | Virginia Commonwealth University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vibration Intervention First Arm | The vibration intervention first and then the no vibration intervention. The order of the intervention was being assessed. |
| FG001 | No Vibration Intervention First Arm | The no vibration intervention session first and then the vibration intervention. The order of the intervention was being assessed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrolled 12 subjects (5 in the no vibration first arm and 7 in the vibration sequence first).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vibration Intervention First Arm | The intervention session first and then the no vibration intervention. The order of the intervention was being assessed. |
| BG001 | No Vibration Intervention First Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Functional Ambulation Profile (FAP) Score | The Functional Ambulation Profile (FAP) score is the gold standard for spatiotemporal gait parameter analysis. For this study, it will be mean calculated by participants walking on the Zeno walkway, which will measure the patient's physical measurements, step length, step time and degree of symmetry., dynamic base of support and the use of ambulatory aids are factored into the score. The Zeno instrumented walkway (PKMAS) is a 20-foot computerized walkway containing sensor pads. A full FAP (Functional Ambulation Profile) score is calculated by deducting points from a maximum score of 100 and the minimum is a 0, with points being subtracted based on deviations from normal gait patterns observed during a self-selected velocity walking trial; essentially, a higher score (closer to 100) indicates closer to normal gait function while a lower score (closer to 0) represents greater gait impairments. No subscales. This is reported as the mean of the two scores for each session aggregated. | The subject received the PDVibe2 vibration intervention turned on session and a session with the PDVibe2 vibration intervention turned off | Posted | Mean | Standard Deviation | FAP score on a scale | Throughout study completion, from 9 to 34 days. |
During the intervention periods and the wash-out period, 21 days total.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vibration Intervention Session | The subject received the PDVibe2 vibration intervention turned on session |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ingrid Pretzer-Aboff | Virginia Commonwealth University | 302-893-9504 | iaboff@vcu.edu |
Not provided
| 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 9, 2021 | Jan 27, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2021 | Jan 27, 2025 | ICF_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| No vibration session | Device | The PDVibe2 is owned by Resonate Forward, LLC and will be loaned to Virginia Commonwealth University (VCU) for this project. The device is non-invasive, lightweight, untethered, contains a rechargeable battery, and is worn on both feet and ankles. During this session, PDVibe2 delivers no vibration but is still worn. The internal circuitry has been miniaturized, is encased in a small box, and is attached to the ankle using a soft flexible band. |
|
|
| Throughout study completion, between 9 to 34 days. |
| Berg Balance Scale (BBS) | The Berg Balance Scale (BBS) assesses balance via performing 14 functional activities. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score is a summation or total of all items and ranges from 0 to 56. Higher scores indicate less risk of falls. A cutoff score of 45 has been traditionally identified as a useful cutoff to predict falls in those who scored below the cutoff score. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. So the closer to 0, the least function and the closer to 56, the more function a subject would have. This is reported as the mean of the scores for each session aggregated. | Throughout study completion, between 9 to 34 days. |
| New Freezing of Gait Questionnaire (nFOG-Q) | The New Freezing of Gait Questionnaire (nFOG-Q) is a six-item questionnaire that uses a 5-point scale that ranges from 0 = absence of symptoms to 4 = most severe stage. The total score ranges from 0 to 24; higher scores (closer to 24) correspond to more severe and lower scores (closer to 0) have fewer symptoms on the New Freezing of Gait Questionnaire (nFOG-Q). To objectively assess FOG severity, Parkinson's disease (PD) subjects are asked to perform brief and standardized FOG-provoking tasks in clinical centers. Common tasks include timed-up-and-go (TUG), 180 or 360 degrees turning while walking and 360-degree turning-in-place (360Turn). This is reported as the mean of the scores for each session aggregated. | Throughout study completion, between 9 to 34 days. |
| Fall Efficacy Scale - International | The Fall Efficacy Scale - International includes 16 items assessing fear of falling in different scenarios, in a community-dwelling older population. Individuals are instructed to rate each activity on a four-point Likert scale, depending on how concerned they are that they may fall when performing certain activities. Items are scored from 1 = Not at all concerned to 4 = very concerned. The total score ranges from 16 - 64. The higher the score (the closer to 64) the greater the fear of falling by the subject and the lower the score (closer to 16) the less fear of falling by the subject using the Fall Efficacy Scale - International. This is reported as the mean of the scores for each session aggregated. | Throughout study completion, between 9 to 34 days |
The no intervention session first and then the vibration intervention. The order of the intervention was being assessed.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | PDVibe2 Vibration Intervention Session | The PDVibe2 vibration intervention session |
| OG001 | No Vibration Intervention Session | The no vibration intervention session |
|
|
| Primary | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS),will be used to assess the total burden of motor Parkinson Disease (PD) symptoms and impact on activities of daily living. There are four sections to this scale and all sections use a scale of 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe)lower scores are better and indicate less disability. Part II: 13 items about Activities of Daily Living, score range 0-52. Part III: 18 items PD motor signs, score range is 0-72, Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). Part IV: 6 items, assesses dyskinesia (excessive motion) and motor fluctuations (medication is working or not), range is 0-24. Parts II-IV total scores. This is reported as the mean of the scores for each session aggregated. The smaller the overall number (closer to 0), the less disability and the greater the number (closer to 148) the greater the disability. | The subject received the PDVibe2 vibration intervention turned on session and a session with the PDVibe2 vibration intervention turned off | Posted | Mean | Standard Deviation | MDS-UPDRS score on scale | Throughout study completion, from 9 to 34 days. |
|
|
|
| Secondary | Timed Up and Go (TUG) Test | The Timed Up and Go (TUG) Test is a one-item performance test. The participant starts by sitting in a chair, then stand up, walk 3 meters, turn around, walk back, and sit down. Participants are timed in seconds. TUG is used to identify/screen elderly individuals who are prone to falls. Lower times/measured in seconds is better. The Timed Up and Go (TUG) test is scored based on the time it takes to complete the test, in seconds: < 10 seconds: Normal < 20 seconds: Good mobility, can walk outside alone, no walking aid needed < 30 seconds: Walking and balance problems, cannot walk outside alone, walking aid needed So less than 10 seconds would be normal and 30 seconds or more may indicate a higher risk of falling. This is reported as the mean of the scores for each session aggregated. | The subject received the PDVibe2 vibration intervention turned on session and a session with the PDVibe2 vibration intervention turned off | Posted | Mean | Standard Error | seconds | Throughout study completion, between 9 to 34 days. |
|
|
|
| Secondary | Berg Balance Scale (BBS) | The Berg Balance Scale (BBS) assesses balance via performing 14 functional activities. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score is a summation or total of all items and ranges from 0 to 56. Higher scores indicate less risk of falls. A cutoff score of 45 has been traditionally identified as a useful cutoff to predict falls in those who scored below the cutoff score. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. So the closer to 0, the least function and the closer to 56, the more function a subject would have. This is reported as the mean of the scores for each session aggregated. | The subject received the PDVibe2 vibration intervention turned on session and a session with the PDVibe2 vibration intervention turned off | Posted | Mean | Standard Error | BBS score on a scale | Throughout study completion, between 9 to 34 days. |
|
|
|
| Secondary | New Freezing of Gait Questionnaire (nFOG-Q) | The New Freezing of Gait Questionnaire (nFOG-Q) is a six-item questionnaire that uses a 5-point scale that ranges from 0 = absence of symptoms to 4 = most severe stage. The total score ranges from 0 to 24; higher scores (closer to 24) correspond to more severe and lower scores (closer to 0) have fewer symptoms on the New Freezing of Gait Questionnaire (nFOG-Q). To objectively assess FOG severity, Parkinson's disease (PD) subjects are asked to perform brief and standardized FOG-provoking tasks in clinical centers. Common tasks include timed-up-and-go (TUG), 180 or 360 degrees turning while walking and 360-degree turning-in-place (360Turn). This is reported as the mean of the scores for each session aggregated. | The subject received the PDVibe2 vibration intervention turned on session and a session with the PDVibe2 vibration intervention turned off | Posted | Mean | Standard Error | (nFOG-Q) score on a scale | Throughout study completion, between 9 to 34 days. |
|
|
|
| Secondary | Fall Efficacy Scale - International | The Fall Efficacy Scale - International includes 16 items assessing fear of falling in different scenarios, in a community-dwelling older population. Individuals are instructed to rate each activity on a four-point Likert scale, depending on how concerned they are that they may fall when performing certain activities. Items are scored from 1 = Not at all concerned to 4 = very concerned. The total score ranges from 16 - 64. The higher the score (the closer to 64) the greater the fear of falling by the subject and the lower the score (closer to 16) the less fear of falling by the subject using the Fall Efficacy Scale - International. This is reported as the mean of the scores for each session aggregated. | The subject received the PDVibe2 vibration intervention turned on session and a session with the PDVibe2 vibration intervention turned off | Posted | Mean | Standard Error | Fall Efficacy Scale score | Throughout study completion, between 9 to 34 days |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | No Vibration Intervention Session | The subject received a session with the PDVibe2 vibration intervention turned off | 0 | 12 | 0 | 12 | 3 | 12 |
| Leg cramp/sore calf | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Baseline-MDS UPDRS 3 Total |
|
| Post-treatment MDS UPDRS 3 Total |
|