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

A Novel Instrument to Address Freezing of Gait in Parkinson's Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Time periods mentioned: 1 week
  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study protocol involves two clinic visits."
  • "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."
  • "Participants will use ParkinSense during awake hours for one week, and refrain from using the system during the alternate week."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the ParkinSense system helps people with Parkinson's disease spend less time frozen, or unable to keep walking. It is for people who have this problem, called freezing of gait. Participants will wear the system during one lab visit, then use it at home for two weeks.

The goal of this clinical trial is to learn if the ParkinSense system, a customizable, multimodal, and adaptable cueing system, can assist with freezing of gait (FOG) in patients with Parkinson's disease. The main question it aims to answer is: is the percent of time spent frozen reduced when using the system compared to not using the system? Participants will be asked to take part in a single-visit laboratory study where they will wear the system in a controlled environment, followed by a two weeks of home use.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of idiopathic Parkinson's disease, meaning the cause is unknown.
  • Have previously been found to have freezing of gait.
  • Be able to walk.
  • Score 21 or higher on the Montreal Cognitive Assessment (MoCA), a test of memory and thinking.

Who can't join

  • Have peripheral neuropathy, or nerve damage outside the brain and spinal cord.
  • Have dementia, a condition that affects memory and thinking.
  • Have severe walking problems not caused by Parkinson's disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

VA