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

NCT ID: NCT06385392

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-11
• Study Completion Date: 2025-04-28

Brief Summary

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.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

People with Parkinson's disease and Freezing of Gait using experimental insole and haptic module

Haptic module and insole device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martha A Nance, MD

Role: PRINCIPAL_INVESTIGATOR

Struthers Parkinson's Center

Locations

Struthers Parkinson's Center

Golden Valley, Minnesota, United States

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

A23-354

Identifier Type: -

Identifier Source: org_study_id