RecruitingNot ApplicableNCT06602544

Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

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


Sponsor

Harvard Medical School (HMS and HSDM)

Enrollment

20 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria8

  • 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

Exclusion Criteria6

  • 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

Interventions

DEVICERobotic Apparel

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.


Locations(2)

Harvard Science and Engineering Complex

Allston, Massachusetts, United States

Boston University Sargent College of Health and Rehabilitation Sciences

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06602544


Related Trials