Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorHarvard Medical School (HMS and HSDM)

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Robotic Apparel

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Harvard Medical School (HMS and HSDM)

Lead sponsor

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Boston University

Collaborator