Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - 95 |
| Updated: | 3/22/2019 |
| Start Date: | April 2020 |
| End Date: | August 2021 |
| Contact: | Gina Blackwell |
| Email: | gina.blackwell@vcuhealth.org |
| Phone: | 804-921-9990 |
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 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.
vibration (delivered by an experimental device called PDVibe2) on freezing of gait 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.
Participation will require up to 8 treatment sessions within 5 days (no more than 2 sessions
in one day) plus an additional day for screening and another for follow-up (7 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.
in one day) plus an additional day for screening and another for follow-up (7 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.
Inclusion criteria:
- age 21 years or older
- PD diagnosed by a movement disorder specialist for 3 months or longer prior to
recruitment
- PD medication regimen is stable over the last 3 months with no changes
- Hoehn & Yahr stage 2 (N = 13) and H&Y stage 3 (N=13),
- able to walk independently or with a simple assistive device (e.g., cane, walker)
- observed by the research team to have PD related gait disturbance such as FOG,
shortened or irregular stride lengths, irregular step cadence, slowed speed while on
their regular treatment regimen.
Exclusion Criteria:
- diagnosed with a known Parkinson plus syndrome
- were previously exposed to vibration treatment for gait and balance
- presence of dementia (Montreal Cognitive Assessment < 21)
- additional disorders (not related to PD)impairing gait, stance, balance or
coordination (e.g. stroke, leg amputations, or multiple sclerosis)
- history of implantable cardiac device or any other implanted electronic device except
a deep brain stimulator (DBS)
- use of braces/orthotics that assist with walking
- are currently in physical therapy (PT) treatment for balance or gait
- peripheral neuropathy by exam
- any condition that, in the opinion of the PIs, would compromise participant safety,
data integrity, or data interpretation.
- Children under the age of 18
- Prisoners
- Women who are pregnant or may become pregnant during the course of this study since
the safety of this device for an unborn child is unknown.
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