Health TrialsbyHealthPanel

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

ConditionFreezing of Gait Symptoms in Parkinson Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorBarron Associates, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Peripheral neuropathy

Dementia

Severe gait abnormalities not related to Parkinson's Disease.

Trial design

Design model

Crossover

Treatments tested in this trial

  • ParkinSense System

    Device

    The noninvasive, body-worn ParkinSense system is intended help patients with Parkinson's prevent freezing of gait (FOG) and resume ambulation when FOG occurs. The system provides multiple modes of cueing, offers extensive cue personalization, and automatically detects FOG and issues one or more cues that have been tailored to an individual when FOG is detected.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ParkinSense first, then ControlExperimental treatment 1 intervention
Group B: Control first, then ParkinSenseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent of time frozen

The total duration of annotated FOG events for that sequence divided by the total duration of the sequence.

Time frame
Day 1 (during the laboratory visit)

Secondary outcomes

1

Gait speed

Average gait speed (meters/second)

Time frame
Day 1
2

Step Cadence

Average steps per second during each sequence

Time frame
Day 1
3

Step cadence variability

The variability in step cadence for each sequence (steps/second)

Time frame
Day 1
4

Average step length

The average step length for each sequence (meters).

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barron Associates, Inc.

Lead sponsor

National Institute on Aging (NIA)

Collaborator

University of Virginia

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: