RecruitingNot ApplicableNCT06602544

Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

Preventing Freezing of Gait in Parkinson's Disease Using Soft Robotic Apparel


Sponsor

Harvard Medical School (HMS and HSDM)

Enrollment

20 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a wearable robotic garment that delivers subtle vibrations to the legs and body to see if it can reduce or prevent "freezing of gait" — a symptom of Parkinson's disease where a person suddenly feels unable to move their feet when walking. **You may be eligible if...** - You are between 18 and 90 years old - You have Parkinson's disease and experience freezing of gait - You can walk at least 20 meters independently (with or without a walking aid) - You scored 21 or higher on the Montreal Cognitive Assessment (MoCA) cognitive screening - You can communicate effectively with study staff - You are available to attend 8 study visits **You may NOT be eligible if...** - You have had more than 2 falls in the past month due to walking problems (though exceptions may be made) - You had major surgery in the last 6 months that affects walking (exceptions may apply) - You are missing a limb affecting your gait - You have chronic pain that significantly interferes with walking - You have serious medical conditions unrelated to gait that could interfere with participation - You do not show observable freezing of gait during evaluation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERobotic Apparel

A robotic apparel system is a portable, lightweight textile-based wearable robot that is worn around the waist and thighs. The apparel provides assistive flexion moment about the hip joint during the swing phase of gait by spooling in a cable that connects the thigh wraps to the front of the waist belt. Inertial measurement units embedded in the thigh wraps are used to control the timing of the robotic apparel assistance. Robotic apparel assistance magnitude is delivered as a small percentage of the bodyweight of the wearer.


Locations(2)

Harvard Science and Engineering Complex

Allston, Massachusetts, United States

Boston University Sargent College of Health and Rehabilitation Sciences

Boston, Massachusetts, United States

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NCT06602544


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