Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

Recruiting now · Not applicable

Conditions studied: Parkinson Disease (PD)

In brief

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 is formally defined as a "brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk." This debilitating gait phenomena is very common in PD, occurring in up to 80% of individuals with severe PD. When FoG arrests walking, serious consequences can occur such as loss of balance, falls, injurious events, consequent fear of falling, and increased hospitalization. Wearable robots are capable of augmenting spatiotemporal gait mechanics and are emerging as viable solutions for locomotor assistance in various neurological populations. For the proposed study, our goal is to understand how low force mechanical assistance from soft robotic apparel can best mitigate gait decline preceding a freezing episode and subsequent onset of FoG by improving spatial (e.g. stride length) and temporal features (e.g. stride time variability) of walking. We hypothesize that the ongoing gait-preserving effects can essentially minimize the accumulation of motor errors that lead to FoG. Importantly, the autonomous assistance provided by the wearable robot circumvents the need for cognitive or attentional resources, thereby minimizing risks for overloading the cognitive systems -- a known trigger for FoG, thus enhancing the repeatability and robustness of FoG-preventing effects.

Key facts

Study ID

NCT06602544

Run by

Harvard Medical School (HMS and HSDM)

People needed

20

Starts

2024-09-03

Expected to finish

2027-09-01

Last updated by the study team

2025-07-18

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Harvard Science and Engineering Complex — Allston, Massachusetts, United States (enrolling)
• Boston University Sargent College of Health and Rehabilitation Sciences — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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