Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject's arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in persons with Parkinson's disease (PD).
Participation will be completed in one visit at VCU Parkinson's and Movement Disorders Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part III will be repeated both during and after the therapy. Participants will be asked to provide feedback about the device, the therapy session and how they are feeling.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower dose vibration | Experimental | RMBand lower dose vibration |
|
| Higher dose vibration | Experimental | RMBand higher dose vibration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RMBand lower dose | Device | Light-weight portable device that delivers low dose vibration to the arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 - 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off. |
| Clinical Rating for Tremor | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 - 14 will be used to report average changes in tremor. Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 - 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. | Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. . |
| Objective Measurement of Tremor Frequency (Hz) | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. |
| Objective Measurement of Tremor Amplitude (mm). | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. |
Not provided
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 |
| 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 | Low Dose Vibration | RMBand lower dose vibration RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm |
| FG001 | High Dose Vibration | RMBand higher dose vibration RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lower Dose Vibration | RMBand lower dose vibration RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm |
| BG001 | Higher Dose Vibration | RMBand higher dose vibration RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 - 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Posted | Mean | Standard Deviation | score on a scale | This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off. |
|
two hours, during time of study activities
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 | Lower Dose Vibration | RMBand lower dose vibration RMBand lower dose: Light-weight portable device that delivers low dose vibration (frequency of 80 Hz) to the arm |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| muscle tightness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | tightness in muscles in right shoulder and neck |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ingrid Pretzer-Aboff | Virginia Commonwealth University | 804-828-3340 | iaboff@vcu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 1, 2018 | Dec 11, 2019 | ICF_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2018 | Nov 12, 2020 | Prot_SAP_002.pdf |
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
| RMBand higher dose | Device | Light-weight portable device that delivers higher dose vibration to the arm |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Clinical Rating Scale for Tremor, total score | Mean | Standard Deviation | units on a scale |
|
| MDS UPDRS II - IV total | Movement Disorder Society Unified Parkinson Rating Scale, (MDS UPDRS, score for parts II - !V. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Higher Dose Vibration |
RMBand high dose vibration RMBand: Light-weight portable device that delivers higher dose vibration to the arm |
|
|
| Primary | Clinical Rating for Tremor | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 - 14 will be used to report average changes in tremor. Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 - 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. | Posted | Mean | Standard Deviation | score on a scale | Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. . |
|
|
|
| Primary | Objective Measurement of Tremor Frequency (Hz) | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Posted | Mean | Standard Deviation | hertz | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. |
|
|
|
| Primary | Objective Measurement of Tremor Amplitude (mm). | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Posted | Mean | Standard Deviation | millimeters | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Higher Dose Vibration | RMBand higher dose vibration RMBand higher dose: Light-weight portable device that delivers higher dose (frequency of 160 Hz) vibration to the arm | 1 | 15 | 0 | 15 | 1 | 15 |
|
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Post vibration |
|
| Post Vibration |
|
| Post vibration |
|