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

NCT06385392 | Completed

• 1 other identifier: A23-354
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 2

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

Keywords

Freezing of Gait

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Device: Haptic module and insole device

Interventions

Haptic module and insole device 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.

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

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (2)

Struthers Parkinson's Center

Golden Valley, Minnesota, 55427, United States

Location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Martha A Nance, MD

  Struthers Parkinson's Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 26, 2024
• Study Start: September 11, 2024
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)