Clinical Trial

Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

Study acronym: XF
Recruiting
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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 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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-09-17; most recent amendment 2025-07-15.
Trial Details
NCT Number NCT06602544
Lead Sponsor Harvard Medical School (HMS and HSDM)
Collaborators: Michael J. Fox Foundation for Parkinson's Research, Boston University
Conditions Parkinson Disease (PD)
Enrollment 20 participants
Start Date 2024-09-03
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-07-18