A System to Help With Freezing of Gait in Parkinson's Patients

The ParkinSense instrument will be evaluated in a clinical trial with a laboratory and a home component. The study protocol involves two clinic visits. The first visit will involve consent and screening. The laboratory protocol will also take place during the this visit. The home-based protocol will follow the laboratory protocol. After the home protocol, the participant will return a final time to drop off the unit and complete the follow-up interview/questionnaires.

-Laboratory Protocol. The purpose of the laboratory protocol will be to evaluate the ParkinSense instrument in a controlled setting with respect to freezing of gait (FOG) prevalence and physical capacity metrics (viz., gait speed, step cadence, step cadence variability, and average step length).

Consented participants will be shown the ParkinSense instrument, and its function and purpose will be fully explained. Participants will then perform a trial run of the protocol, with guidance from study personnel, to familiarize them with ParkinSense and to allow the cue presentation to be initially personalized. When the participant is satisfied with the operation of ParkinSense, the study will proceed with the protocol discussed below.

The study protocol is designed to elicit FOG. The protocol will consist of the following activities: (1) a timed-up-and-go (TUG) test where the patient will sit in a chair, get up (without verbal prompting), walk 3 m, turn 180 degrees, walk back (as rapidly as possible in both directions), and then sit down in the chair; (2) a cognitive TUG (C-TUG), where the patient will perform a TUG while counting backwards by 3 starting from a random number provided by the PT; (3) a manual TUG (M-TUG), where the patient will perform a TUG while carrying a cup of water on a tray; and (4) the participant will be asked to walk through several doorways of different sizes and into a small room, turn 360 degrees from standstill, and then walk back through the doorways again.

Participants will perform the same protocol twice after the trial run, once while wearing the ParkinSense instrument and once without wearing the system. The order of the test (ParkinSense vs. no ParkinSense) will be randomized in a crossover design. The trials will be video recorded for FOG event and duration scoring. In order to collect the gait parameters of interest, participants will be asked to wear commercial gait tracking insoles during the study. Once the protocol has been completed, the participant's ParkinSense instrument will be packed into its carrying case, and the participant will be instructed regarding the home-based component.

-Home-based Protocol. The purpose of the home-based study component is to provide patients with real-world use experience, inform refinements and enhancements to the ParkinSense device, ascertain usability and user-acceptance of the Phase II prototype, and compare overall activity levels of participants when the ParkinSense is being used vs. when it is not being used. Participants will be provided a ParkinSense system and a research-grade activity tracker for this two-week field trial. They will have been trained regarding proper use of the ParkinSense device by study personnel under the Laboratory Protocol.

Participants will use ParkinSense during awake hours for one week, and refrain from using the system during the alternate week. The week chosen to use the ParkinSense system will be randomized in a crossover design similar to the laboratory component. The time spent wearing the system will be tracked. Participants will be asked to use the activity tracker for both weeks in order to track activity throughout the study.

Participants will complete the Freezing of Gait Questionnaire (FOG-Q) and a Hauser Parkinson's Disease Diary daily for the duration of the at-home study (alternatively, a caretaker can fill out the forms with the patient's input). Participants will complete the Parkinson's Disease Questionnaire (PDQ-8) at the end of each week. At the completion of the study, participants will be interviewed and asked to complete the System Usability Scale.

Inclusion criteria

• Confirmed diagnosis of idiopathic Parkinson's Disease
• Prior identified presence of Freezing of Gait
• Ability to ambulate;
• Montreal Cognitive Assessment (MOCA) MOCA questionnaire score >=21.

Exclusion criteria

• Peripheral neuropathy
• Dementia
• Severe gait abnormalities not related to Parkinson's Disease.