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

HealthPartners Institute

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: Haptic module and insole device

Study type: Observational

Funder types: Other

Identifiers

NCT06385392

A23-354

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to provide and provision of signed and dated informed consent form.
• Age 45-80
• 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

Trial design

36 participants in 1 patient group

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

Treatment:

Device: Haptic module and insole device