Preventing Freezing of Gait in Parkinson's Disease Using Soft Robotic Apparel

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Harvard Science and Engineering Complex
RECRUITING
Allston
Boston University Sargent College of Health and Rehabilitation Sciences
RECRUITING
Boston
Contact Information
Primary
Franchino Porciuncula, EdD, PT, DScPT
fporciun@bu.edu
617-353-7525
Backup
Teresa Baker, DPT
nwendel@bu.edu
617-353-7525
Time Frame
Start Date: 2024-09-03
Estimated Completion Date: 2027-09
Participants
Target number of participants: 20
Treatments
Experimental: Multi-visit ambulatory activities with soft robotic apparel
Participants will engage in ambulatory activities (i.e. straight-line walking, turning) with and without the assistance of robotic apparel, performed across multiple visits under various freezing-of-gait (FoG) provoking scenarios
Related Therapeutic Areas
Sponsors
Collaborators: Michael J Fox Foundation for Parkinson Research, Boston University
Leads: Harvard Medical School (HMS and HSDM)

This content was sourced from clinicaltrials.gov

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