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

Last updated: September 18, 2024
Sponsor: HealthPartners Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Haptic module and insole device

Clinical Study ID

NCT06385392
A23-354
  • Ages 45-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 inaccordance with the PD Society Brain Bank diagnostic criteria.

  • Evidence of presence of freezing gait as a symptom. Determined from combination ofclinical examination (observation of freezing) and New Freezing of GaitQuestionnaire (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 adhereto the regimen during the study.

  • Ability to don and doff the insole and haptic module independently or have dailyassistance during the study intervention.

Exclusion

Exclusion Criteria:

  • Non-English speaking

  • History of musculoskeletal disorders that significantly affect movement of lowerlimbs as determined at the time of enrollment.

  • Other significant neurological disorders that may affect participation orperformance in the study.

  • Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.

  • Hallucinations

  • Non-ambulatory

  • Legally Blind

  • Symptomatic hypotension

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Haptic module and insole device
Phase:
Study Start date:
September 11, 2024
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Struthers Parkinson's Center

    Golden Valley, Minnesota 55427
    United States

    Active - Recruiting

  • HealthPartners Neuroscience Center

    Saint Paul, Minnesota 55130
    United States

    Active - Recruiting

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