Status:
RECRUITING
Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease
Lead Sponsor:
Harvard Medical School (HMS and HSDM)
Collaborating Sponsors:
Michael J Fox Foundation for Parkinson Research
Boston University
Conditions:
Parkinson Disease (PD)
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Freezing-of-gait (FoG) in Parkinson Disease (PD) is one of the most vivid and disturbing gait phenomena in neurology. Often described by patients as a feeling of "feet getting glued to the floor," FoG...
Detailed Description
Wearable robots are capable of augmenting spatiotemporal gait mechanics and are emerging as viable solutions for locomotor assistance in various neurological populations. Given the breakdown of spatio...
Eligibility Criteria
Inclusion
- 18-90 years old
- Self-reported Freezing of Gait due to PD
- Score of 21 or higher on the cognitive screening test (Montreal Cognitive Assessment Score (MoCA))
- Independent ambulation (with or without an assistive device, no physical assistance) for at least 20 meters
- Able to understand, communicate, and be understood by study staff
- Provide HIPAA Authorization to allow communication with the participant's treating physician/provider for medical clearance (if deemed necessary by study clinical team) to verify self-reported medical history (if deemed necessary by study clinical team)
- Provide informed consent
- Ability to participate in 8 research study visits
Exclusion
- More than 2 falls in the previous month, as a result of gait impairment (may enroll under clinician discretion)
- Major surgery in the last 6 months that interferes with walking (may enroll under clinician discretion)
- Gait deficits due to missing limbs
- Experience chronic pain that interferes with walking ability (may enroll under clinician discretion)
- Serious co-morbidities (unrelated to gait impairment) that may interfere with ability to participate in research (e.g. cardiovascular, neurological, skin, and vascular conditions such as acute, ongoing/unmanaged deep vein thrombosis)
- No observable freezing-of-gait
Key Trial Info
Start Date :
September 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06602544
Start Date
September 3 2024
End Date
September 1 2027
Last Update
July 18 2025
Active Locations (2)
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1
Harvard Science and Engineering Complex
Allston, Massachusetts, United States, 02134
2
Boston University Sargent College of Health and Rehabilitation Sciences
Boston, Massachusetts, United States, 02215