NCT06602544Recruiting
Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease
Preventing Freezing of Gait in Parkinson's Disease Using Soft Robotic Apparel
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 17 Sept 2024
- Start date
- 3 Sept 2024
- Primary completion date
- Sept 2027
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Diseases
- Parkinson disease
- NCT number
- NCT06602544
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 3 Sept 2024 to the primary completion date, Sept 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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)
Other
- Gait deficits due to missing limbs
- Experience chronic pain that interferes with walking ability (may enroll under clinician discretion)
- No observable freezing-of-gait
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harvard Science and Engineering Complex Coordinator of this site? Confirm its status | Allston | United States | Recruiting |
| Boston University Sargent College of Health and Rehabilitation Sciences Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.