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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 45 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Struthers Parkinson's Center
Golden Valley, Minnesota 55427
Contact:
Research Coordinator
651-495-6363
ClinicalTrials@HealthPartners.com

HealthPartners Neuroscience Center
Saint Paul, Minnesota 55130
Contact:
Clinical Trial Coordinator
651-495-6363
ClinicalTrials@HealthPartners.com

More Details

Status
Recruiting
Sponsor
HealthPartners Institute

Study Contact

Clarissa M Howe
651-495-6363
Clarissa.M.Howe@HealthPartners.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.