Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

Not Applicable

Recruiting

• Conditions: Parkinson Disease (PD)
• Interventions: Device: Robotic Apparel

• Registration Number: NCT06602544
• Lead Sponsor: Harvard Medical School (HMS and HSDM)

Brief 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.

Detailed Description

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 8-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.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-03
• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multi-visit ambulatory activities with soft robotic apparel	Robotic Apparel	Participants will engage in ambulatory activities (i.e. straight-line walking, turning) with and without the assistance of robotic apparel, performed across multiple visits under various freezing-of-gait (FoG) provoking scenarios

Primary Outcome Measures

Name	Time	Method
Change in percent time spent freezing	Visit 8 (within 6 months after enrollment)	Percent time spent freezing refers to cumulative duration spent freezing divided by the total duration of the task, expressed as percentage. Change in this outcome measure refers to the difference in percent time spent freezing during activities with and without assistance of robotic apparel.
Change in stride length	Visit 8 (within 6 months after enrollment)	Stride length is the Euclidian distance between a point at heel strike at the beginning of gait cycle and a point at heel strike at the subsequent gait cycle. Change in this outcome measure refers to difference in stride length during activities with and without assistance of robotic apparel.

Secondary Outcome Measures

Name	Time	Method
Change in freezing-of-gait ratio	Visit 8 (within 6 months after enrollment)	Freezing-of-gait ratio refers to the ratio between total power in the 3-8Hz band and the total power in the 0.5-3Hz band in the shank inertial measurement units. Change in this outcome measure refers to difference in freezing-of-gait ratio during activities with and without assistance of robotic apparel.
Change in 2-Minute Walk Test Distance	Visit 8 (within 6 months after enrollment)	2-Minute Walk Test distance refers to the farthest distance covered during 2 minutes of walking. Change in this outcome measure refers to difference in the 2-Minute Walk Test distance with and without assistance of robotic apparel.
Change in range of motion	Visit 4 (within 6 months after enrollment)	Range of motion refers to the range (difference in maximum and minimum) of sagittal plane motion of the hip, knee, and ankle joints throughout a gait cycle. Change in this outcome measure refers to difference in the hip, ankle, and knee range-of-motion during activities with and without assistance of robotic apparel.
Change in cadence	Visit 8 (within 6 months after enrollment)	Cadence refers to the number of steps or strides taken per minute. Change in this outcome measure refers to difference in the cadence during activities with and without assistance of robotic apparel.
Change in stride time variability	Visit 8 (within 6 months after enrollment)	Stride time variability refers to the difference in the coefficient of variance of stride time in each activity bout. Change in this outcome measure refers to difference in the stride time variability during activities with and without assistance of robotic apparel.
Change in peak foot-to-floor angle	Visit 4 (within 6 months after enrollment)	Peak foot-to-floor angle refers to the maximum angle of the foot relative to ground as the foot dorsiflexes at heel strike, measured by the foot inertial measurement unit. Change in this outcome measure refers to difference in the stride time variability during activities with and without assistance of robotic apparel.

Trial Locations

Locations (2)

Harvard Science and Engineering Complex; 🇺🇸 Allston, Massachusetts, United States

Boston University Sargent College of Health and Rehabilitation Sciences; 🇺🇸 Boston, Massachusetts, United States