Clinical trial NCT06385392: Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.
Official title: Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Freezing of Gait
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 31
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: To validate the haptic module and insole device system and evaluate its efficacy with an in-community clinical trial.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Golden Valley
country: United States
facility: Struthers Parkinson's Center
state: Minnesota
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: Struthers Parkinson's Center
name: Martha A Nance, MD
role: PRINCIPAL_INVESTIGATOR
References: