Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.

The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Haptic module and insole device

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Golden Valley, Minnesota, United States, 55427
      • Struthers Parkinson's Center
    • Saint Paul, Minnesota, United States, 55130
      • HealthPartners Neuroscience Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants aged 45-80 who have a diagnosis of Parkinson's disease with Freezing of Gait symptoms who live in the community.

Description

Inclusion Criteria:

• Ability to provide and provision of signed and dated informed consent form.
• Age 45 or older
• Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.
• Evidence of presence of freezing gait as a symptom. Determined from combination of clinical examination (observation of freezing) and New Freezing of Gait Questionnaire (NFOG).
• Able to complete a 2-minute walk test at the pre-treatment visit.
• Currently on a stable prescription medication regimen for PD and willing to adhere to the regimen during the study.
• Ability to don and doff the insole and haptic module independently or have daily assistance during the study intervention.

Exclusion Criteria:

• Non-English speaking
• History of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment.
• Other significant neurological disorders that may affect participation or performance in the study.
• Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.
• Hallucinations
• Non-ambulatory
• Legally Blind
• Symptomatic hypotension
• Any condition which would limit sensation in the legs or requires use of wraps, bandages or other items which may limit sensation in the legs (e.g., lymphedema) that would interfere with the performance of the haptic device, in the opinion of the investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
People with Parkinson's disease and Freezing of Gait using experimental insole and haptic module	Device: Haptic module and insole device; System for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Validate the Haptic Module and Insole Device System and Evaluate Its Efficacy With an In-community Clinical Trial.	Change in duration of FOG events. Decreased duration of FOG events indicates higher efficacy of device system.	5 weeks

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Investigators: Principal Investigator: Martha A Nance, MD, Struthers Parkinson's Center

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Actual): April 28, 2025
• Study Completion (Actual): April 28, 2025

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Freezing of Gait
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: A23-354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No