Status:
WITHDRAWN
Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Parkinson Disease
Eligibility:
All Genders
21-95 years
Phase:
NA
Brief Summary
The purpose of this research study is to determine optimum dose of vibration delivered by an experimental device called PDVibe2 required to treat freezing of gait in persons with Parkinson's disease (...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03872115
Start Date
April 18 2019
End Date
April 1 2020
Last Update
October 15 2024
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