Parkinson Disease
Conditions
Keywords
Freezing of Gait
Brief summary
People with Parkinson's disease (PD) may experience a walking problem called freezing of gait (FoG) that can interfere with the person's ability to conduct daily activities. FoG has been described as feeling like one's feet are glued or stuck to the floor. Drug treatments for PD rarely improve FoG. Researchers have found that vibration therapy may help improve FoG. The purpose of this research study is to test the safety, tolerability, and effectiveness of using a wearable device (UG motion sensor, that is the size of a watch) that will recognize FoG and then send a signal to another small watch-like device (PDVibe3) to deliver a vibration stimuli to participant's feet. The researchers believe the vibration stimulus (which feels like a phone on vibration mode) will help reduce FoG in persons with PD. The study is open to people who have been diagnosed with Parkinson's disease, have FoG, and meet the study entry requirements. The PDVibe3 is an investigational device, which means it has not been approved by the U.S. Food and Drug Administration (FDA). The UG motion sensor is also an investigational device.
Detailed description
Usual care for PD involves taking medications to help with disease. In this study, participants will receive usual care. Participants will be asked to have taken their medication before they arrive, and to bring extra medicine with them should their next dose be due while they are at the study site. Participants will be asked to walk on certain paths, and when the device detects a freeze in their gait, they will receive a dose of vibration to their feet. This vibration is felt differently by different people and it may feel very light or a little stronger (like a phone set to vibrate), or it may feel somewhere in between. During the study, participants will be asked to do the following things: 1. Visit the research site at VCU, one time for the study 2. Complete a short cognitive exam 3. Answer questions about their medical history 4. Complete a few brief surveys about fatigue, balance, falls, freezing of gait, quality of life, and activities of daily living 5. Complete a 10-meter walk test 6. Wear the UG motion sensor (which detects FoG) on each ankle 7. Wear the PDVibe3 (which provides vibration) on each ankle 8. Walk five, 5-meter scenarios without vibration, and then again three more times with vibration therapy in a public setting on VCU campus. The five scenarios include: 1. Walking through a narrow passage 2. Walk and turn 540 degrees 3. Walk toward a chair 4. Walk while performing a verbal task 5. Walk through a door before it closes Participants will be able to take breaks at any time if they feel tired. Participants will be photographed and videotaped during the walking sessions, but faces will be blurred so that the recordings will not be identifiable. Participation in this study can last up to 5 hours with several breaks. Approximately 20 individuals will participate in this study.
Interventions
DEVICEUG motion sensor with PDVibe3
UG motion sensor (which detects FoG) on worn each ankle. PDVibe3 (which provides vibration) on worn each ankle
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion * age \>18 years, * Parkinson's disease (PD) diagnosed by a movement disorder specialist using UK Brain Bank criteria, * are able to walk independently or with a simple device (e.g., cane or walker), and * are observed by the research team to have PD-related FoG in at least two of the five previously described common trigger scenarios (i.e., freezing upon gait initiation, walking through tight quarters, freezing when changing directions, approaching a visual target, dual tasking, and stressful, time sensitive situations such as entering an elevator before the doors close). Exclusion * individuals with known Parkinson plus syndrome, * presence of dementia (Montreal Cognitive Assessment \< 21), * an additional disorder (not related to PD) impairing gait, * history of implantable cardiac device or any other implanted electronic device except DBS, * peripheral neuropathy (determined by use of tuning fork to check for ability to feel vibration), * any condition that, in the opinion of the PI, would compromise participant safety, data integrity, or data interpretation, * pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Freezing of Gait (FoG) Episodes | Baseline to final walk task - up to 5 hours | Participants will be videotaped during each walking task and the number of FoG episodes will be counted. Change in number of FoG episodes will be calculated by subtracting the average number of FoG episodes while experiencing vibration vs the number of episodes without vibration. For this test, the null hypothesis of no difference between the treatments versus the alternative hypothesis that the two groups differed. |
| Duration of Freezing of Gait (FoG) Episodes. | Baseline to final walk task - up to 5 hours | Participants will be videotaped during each walking task and the duration of each FoG episodes will be calculated. Change in duration of FoG episodes will be calculated by subtracting the average duration of FoG episodes while experiencing vibration vs the average duration without vibration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vibration Therapy 5-meter walk scenarios with vibration therapy
UG motion sensor with PDVibe3: UG motion sensor (which detects FoG) on worn each ankle.
PDVibe3 (which provides vibration) on worn each ankle | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Vibration Therapy |
|---|---|
| Age, Continuous | 70.9 years STANDARD_DEVIATION 7.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 11 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 10 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Duration of Freezing of Gait (FoG) Episodes.
Participants will be videotaped during each walking task and the duration of each FoG episodes will be calculated. Change in duration of FoG episodes will be calculated by subtracting the average duration of FoG episodes while experiencing vibration vs the average duration without vibration.
Time frame: Baseline to final walk task - up to 5 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vibration Therapy | Duration of Freezing of Gait (FoG) Episodes. | 540 degree turn/no vibration/ total freezing time | 47.67 minutes | Standard Error 12.06 |
| Vibration Therapy | Duration of Freezing of Gait (FoG) Episodes. | 540 degree turn/ vibration/ total freezing time | 52.14 minutes | Standard Error 12.06 |
| Vibration Therapy | Duration of Freezing of Gait (FoG) Episodes. | Narrow path/no vibration/ total freezing time | 34.565 minutes | Standard Error 17.2 |
| Vibration Therapy | Duration of Freezing of Gait (FoG) Episodes. | Narrow path/ vibration/ total freezing time | 43.505 minutes | Standard Error 17.2 |
Primary
Number of Freezing of Gait (FoG) Episodes
Participants will be videotaped during each walking task and the number of FoG episodes will be counted. Change in number of FoG episodes will be calculated by subtracting the average number of FoG episodes while experiencing vibration vs the number of episodes without vibration. For this test, the null hypothesis of no difference between the treatments versus the alternative hypothesis that the two groups differed.
Time frame: Baseline to final walk task - up to 5 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vibration Therapy | Number of Freezing of Gait (FoG) Episodes | no vibration 540 degree turn/number of freezes | 3.75 number of freezes | Standard Error 0.765 |
| Vibration Therapy | Number of Freezing of Gait (FoG) Episodes | vibration 540 degree turn/number of freezes | 5.17 number of freezes | Standard Error 0.765 |
| Vibration Therapy | Number of Freezing of Gait (FoG) Episodes | no vibration narrow path/number of freezes | 4.0 number of freezes | Standard Error 1.205 |
| Vibration Therapy | Number of Freezing of Gait (FoG) Episodes | vibration narrow path/number of freezes | 3.63 number of freezes | Standard Error 1.205 |