RECRUITING

Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-03
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06602544

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-90 years old
  2. * Self-reported Freezing of Gait due to PD
  3. * Score of 21 or higher on the cognitive screening test (Montreal Cognitive Assessment Score (MoCA))
  4. * Independent ambulation (with or without an assistive device, no physical assistance) for at least 20 meters
  5. * Able to understand, communicate, and be understood by study staff
  6. * 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)
  7. * Provide informed consent
  8. * Ability to participate in 8 research study visits
  1. * More than 2 falls in the previous month, as a result of gait impairment (may enroll under clinician discretion)
  2. * Major surgery in the last 6 months that interferes with walking (may enroll under clinician discretion)
  3. * Gait deficits due to missing limbs
  4. * Experience chronic pain that interferes with walking ability (may enroll under clinician discretion)
  5. * 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)
  6. * No observable freezing-of-gait

Contacts and Locations

Study Contact

Franchino Porciuncula, EdD, PT, DScPT
CONTACT
617-353-7525
fporciun@bu.edu
Nicholas Wendel, DPT
CONTACT
617-353-7525
nwendel@bu.edu

Principal Investigator

Terry Ellis, PT, PhD
PRINCIPAL_INVESTIGATOR
Boston University
Conor J Walsh, PhD
PRINCIPAL_INVESTIGATOR
Harvard University

Study Locations (Sites)

Harvard Science and Engineering Complex
Allston, Massachusetts, 02134
United States
Boston University Sargent College of Health and Rehabilitation Sciences
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Harvard Medical School (HMS and HSDM)

  • Terry Ellis, PT, PhD, PRINCIPAL_INVESTIGATOR, Boston University
  • Conor J Walsh, PhD, PRINCIPAL_INVESTIGATOR, Harvard University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-03
Study Completion Date2027-09

Study Record Updates

Study Start Date2024-09-03
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • Parkinson Disease
  • Freezing-of-gait
  • Wearable Robot
  • Soft Robotics
  • Gait
  • Rehabilitation

Additional Relevant MeSH Terms

  • Parkinson Disease (PD)