Clinical trial NCT03883217: Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
Official title: Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Gait
Balance
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2019-03-20
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)
* 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.

Primary outcomes:
measure: Functional Ambulation Profile (FAP) Score
timeFrame: Throughout study completion, from 9 to 34 days.
Secondary outcomes:
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III
timeFrame: Throughout study completion, between 9 to 34 days.
measure: Timed Up and Go (TUG) Test
timeFrame: Throughout study completion, between 9 to 34 days.
measure: Berg Balance Scale (BBS)
timeFrame: Throughout study completion, between 9 to 34 days.
measure: Freezing of Gait Questionnaire (FOG-Q)
timeFrame: Throughout study completion, between 9 to 34 days
measure: Fall Efficacy Scale - International
timeFrame: Throughout study completion, between 9 to 34 days.
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ingrid Pretzer-Aboff, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University Health System
name: Leslie Cloud, MD
role: PRINCIPAL_INVESTIGATOR
References: