Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

Part of paid clinical trials in Allston, Massachusetts.

Sponsor
Harvard Medical School (HMS and HSDM)
Study ID
NCT06602544
Status
Recruiting
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Conditions

  • Parkinson Disease (PD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Robotic Apparel — DEVICE
    A robotic apparel system is a portable, lightweight textile-based wearable robot that is worn around the waist and thighs. The apparel provides assistive flexion moment about the hip joint during the swing phase of gait by spooling in a cable that connects the thigh wraps to the front of the waist belt. Inertial measurement units embedded in the thigh wraps are used to control the timing of the robotic apparel assistance. Robotic apparel assistance magnitude is delivered as a small percentage of the bodyweight of the wearer.

Study Details

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 Dates

Start date
Sep 3, 2024
Status verified
Jul 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in percent time spent freezing [ Time Frame: Visit 4 (within 6 months after enrollment) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Harvard Science and Engineering ComplexAllstonMassachusetts02134
Conor J Walsh, PhD
[email protected]
617-496-4269
Christina Lee, PhD
[email protected]
617-353-7525
Conor J Walsh, PhD (PRINCIPAL_INVESTIGATOR)
Boston University Sargent College of Health and Rehabilitation SciencesBostonMassachusetts02215
Terry Ellis, PhD, PT, FAPTA
[email protected]
617-353-7525
Franchino Porciuncula, EdD, PT, DScPT
[email protected]
617-353-7525
Terry Ellis, PhD, PT, FAPTA (PRINCIPAL_INVESTIGATOR)

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By research site
Harvard Science and Engineering Complex· Allston, MABoston University Sargent College of Health and Rehabilitation Sciences· Boston, MA

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