Robotic apparel to help prevent freezing of gait in Parkinson's disease
Preventing Freezing of Gait in Parkinson's Disease Using Soft Robotic Apparel
NA · Harvard Medical School (HMS and HSDM) · NCT06602544
This study is testing if soft robotic clothing can help people with Parkinson's disease walk better and reduce episodes of freezing while they move.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Harvard Medical School (HMS and HSDM) (other) |
| Locations | 2 sites (Allston, Massachusetts and 1 other locations) |
| Trial ID | NCT06602544 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-90 with self-reported freezing of gait due to Parkinson's disease who can walk independently.
Not a fit: Patients who have experienced more than two falls in the previous month or have significant gait deficits due to missing limbs may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mobility and quality of life for patients with Parkinson's disease by reducing episodes of freezing of gait.
How similar studies have performed: Other studies have shown promise in using robotic assistance for gait improvement in neurological populations, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Allston, Massachusetts and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease, Freezing-of-gait, Wearable Robot, Soft Robotics, Gait, Rehabilitation