Recruiting · registry statusTesting wearable robotic clothing for feet that feel stuck
Researchers test robotic apparel designed to help prevent freezing of gait, when a person briefly cannot take the next step.
Testing a treatment or activity · Study reference: NCT06602544
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
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- Start (reported actual date)
- 2024-09-03
- Main measurements finished (planned)
- 2027-09
- Study finished (planned)
- 2027-09
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
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Papers connected to this study
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Who can join?
Ages 18 years to 90 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
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
Full study name & original research details
Official study title
Preventing Freezing of Gait in Parkinson's Disease Using Soft Robotic Apparel
Short title used by the registry
Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease
Original 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.
Further description from the registry
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.
Conditions reported: Parkinson Disease (PD)
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- Robotic Apparel
- Phases
- NA
- Sponsor
- Harvard Medical School (HMS and HSDM)
- Start date reported by registry
- 2024-09-03 (actual)
Registry updated: 2025-07-18 · Status last verified by the registry submitter: 2025-07
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Franchino Porciuncula, EdD, PT, DScPT · 617-353-7525 · fporciun@bu.edu
Teresa Baker, DPT · 617-353-7525 · nwendel@bu.edu
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Harvard Science and Engineering Complex
Allston, Massachusetts, United States
RecruitingConor J Walsh, PhD · 617-496-4269 · walsh@seas.harvard.edu
Christina Lee, PhD · 617-353-7525 · christina_lee@g.harvard.edu
Conor J Walsh, PhD
Boston University Sargent College of Health and Rehabilitation Sciences
Boston, Massachusetts, United States
RecruitingTerry Ellis, PhD, PT, FAPTA · 617-353-7525 · tellis@bu.edu
Franchino Porciuncula, EdD, PT, DScPT · 617-353-7525 · fporciun@bu.edu
Terry Ellis, PhD, PT, FAPTA
Facility not reported
United States
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.