CompletedNCT06385392

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

Sponsor: HealthPartners Institute

Trial Details

ConditionParkinson Disease
InterventionHaptic module and insole device
StatusCompleted
Participants31
Est. Completion28 Apr 2025
Last Updated28 May 2026

Primary Outcome

To Validate the Haptic Module and Insole Device System and Evaluate Its Efficacy With an In-community Clinical Trial.

Eligibility Criteria

Inclusion 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.

Trial Sites

Countries

United States
View Registry Entry

This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service