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Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease
NCT06602544 · Harvard Medical School (HMS and HSDM)
In plain English
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Official title
Preventing Freezing of Gait in Parkinson's Disease Using Soft Robotic Apparel
About this study
Wearable robots are capable of augmenting spatiotemporal gait mechanics and are emerging as viable solutions for locomotor assistance in various neurological populations. Given the breakdown of spatiotemporal gait parameters prior to onset of FoG, we aim to understand how the use of mechanical assistance from a soft robotic apparel can best mitigate gait decline preceding a freezing episode, and subsequent onset of FoG through a multi-day proof-of-concept study. In Aim 1, we will determine the biomechanical mechanisms underpinning the effects of robotic apparel on FoG. We posit that robotic apparel will prevent FoG by supporting natural gait biomechanics and reducing motor errors and gait degradation (i.e., increase stride length, decrease stride variability) known to precede freezing. In Aim 2, we will quantify the impact of robotic apparel in preventing FoG in PD under a variety of walking conditions in a series of controlled laboratory-based experiments. We hypothesize that robotic apparel will be effective in preventing FoG as evidenced by lower percent time spent freezing and lower FoG severity ratio scores (IMU data, video annotation) during walking and turning, resulting in farther walking distances (2-Minute Walk Test) compared to unassisted walking, repeatable across days of testing. Additionally, we hypothesize that robotic apparel will be effective in preventing FoG across various walking contexts (i.e., walking in open spaces, turning, dual-tasking and medication on/off). In Aim 3, we will examine proof-of-concept of robotic apparel to prevent FoG in the home/community during walking, under FoG provoking conditions. We hypothesize that robotic apparel will be effective in preventing FoG, compared to unassisted walking, as evidenced by lower percent time spent freezing and lower FoG severity ratio scores (IMU data, video annotation) during walking in the home/community, including conditions that trigger FoG (e.g., personalized FoG "hotspots).
The study will utilize a soft robotic apparel that has previously shown to demonstrate robust, gait-preserving benefits and FoG prevention in a single-subject repeated measures case study. To examine the effectiveness of the intervention using our robotic apparel, this 9-visit study will collect data on amount of time spent freezing, spatiotemporal gait measures, clinical measures, and patient perspectives on the device during different standardized assessments and freeze-provoking activities across multiple environments (i.e. home, lab) and medication states (on, relative off) with and without the robotic apparel assistance.
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Study design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-03
Estimated completion: 2027-09
Last updated: 2025-07-18
Interventions
Device: Robotic Apparel
Primary outcomes
- • Change in percent time spent freezing (Visit 4 (within 6 months after enrollment))
- • Change in percent time spent freezing (Visit 5 (within 6 months after enrollment))
- • Change in percent time spent freezing (Visit 6 (within 6 months after enrollment))
Sponsor
Harvard Medical School (HMS and HSDM) · other
With: Michael J Fox Foundation for Parkinson Research, Boston University
Contacts & investigators
ContactFranchino Porciuncula, EdD, PT, DScPT · contact · fporciun@bu.edu · 617-353-7525
ContactTeresa Baker, DPT · contact · nwendel@bu.edu · 617-353-7525
InvestigatorTerry Ellis, PT, PhD · principal_investigator, Boston University
InvestigatorConor J Walsh, PhD · principal_investigator, Harvard University
All locations (2)
Harvard Science and Engineering ComplexRecruiting
Allston, Massachusetts, United States
Boston University Sargent College of Health and Rehabilitation SciencesRecruiting
Boston, Massachusetts, United States