Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT06602544

Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

Led by Harvard Medical School (HMS and HSDM) · Updated on 2025-07-18

20

Participants Needed

2

Research Sites

156 weeks

Total Duration

On this page

Sponsors

H

Harvard Medical School (HMS and HSDM)

Lead Sponsor

M

Michael J. Fox Foundation for Parkinson's Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18-90 years old
  • Self-reported Freezing of Gait due to Parkinson Disease
  • Score of 21 or higher on the Montreal Cognitive Assessment (MoCA) cognitive screening test
  • Able to walk independently at least 20 meters, with or without an assistive device, without physical help
  • Able to understand and communicate with study staff
  • Provide HIPAA Authorization for communication with treating physician if needed
  • Provide informed consent
  • Able to attend 8 research study visits
Not Eligible

You will not qualify if you...

  • More than 2 falls in the past month due to gait impairment (may enroll if clinician approves)
  • Major surgery in the last 6 months interfering with walking (may enroll if clinician approves)
  • Gait problems due to missing limbs
  • Chronic pain interfering with walking ability (may enroll if clinician approves)
  • Serious unrelated health conditions that affect participation (e.g., cardiovascular, neurological, skin, vascular issues including unmanaged deep vein thrombosis)
  • No observable freezing-of-gait

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Harvard Science and Engineering Complex

Allston, Massachusetts, United States, 02134

Actively Recruiting

2

Boston University Sargent College of Health and Rehabilitation Sciences

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

F

Franchino Porciuncula, EdD, PT, DScPT

CONTACT

T

Teresa Baker, DPT

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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