Robotic apparel to help prevent freezing of gait in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of soft robotic apparel to assist individuals with Parkinson's disease who experience freezing of gait (FoG). It aims to understand how mechanical assistance can improve gait mechanics and reduce the frequency and severity of FoG episodes. Through a series of controlled laboratory experiments, the study will assess the effectiveness of the robotic apparel in various walking conditions and measure its impact on gait parameters. Participants will undergo multiple visits to evaluate the performance of the robotic device in preventing FoG.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Terry Ellis, PT, PhD — Boston University
• Study coordinator: Franchino Porciuncula, EdD, PT, DScPT
• Email: fporciun@bu.edu
• Phone: 617-353-7525

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.