Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease (XF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease (PD)
• Intervention / Treatment: Device: Robotic Apparel

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 9-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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Franchino Porciuncula, EdD, PT, DScPT; Phone Number: 617-353-7525; Email: fporciun@bu.edu
• Study Contact Backup: Name: Teresa Baker, DPT; Phone Number: 617-353-7525; Email: nwendel@bu.edu

Study Locations

• United States
  • Massachusetts
    • Allston, Massachusetts, United States, 02134
      • Recruiting
      • Harvard Science and Engineering Complex
      • Contact: Conor J Walsh, PhD; Phone Number: 617-496-4269; Email: walsh@seas.harvard.edu
      • Contact: Christina Lee, PhD; Phone Number: 617-353-7525; Email: christina_lee@g.harvard.edu
      • Principal Investigator: Conor J Walsh, PhD
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Boston University Sargent College of Health and Rehabilitation Sciences
      • Contact: Franchino Porciuncula, EdD, PT, DScPT; Phone Number: 617-353-7525; Email: fporciun@bu.edu
      • Contact: Terry Ellis, PhD, PT, FAPTA; Phone Number: 617-353-7525; Email: tellis@bu.edu
      • Principal Investigator: Terry Ellis, PhD, PT, FAPTA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Multi-visit ambulatory activities with soft 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

Device: Robotic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percent time spent freezing	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.	Visit 4 (within 6 months after enrollment)
Change in percent time spent freezing	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.	Visit 5 (within 6 months after enrollment)
Change in percent time spent freezing	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.	Visit 6 (within 6 months after enrollment)
Change in percent time spent freezing	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.	Visit 7 (within 6 months after enrollment)
Change in percent time spent freezing	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.	Visit 8 (within 6 months after enrollment)
Change in stride length	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.	Visit 4 (within 6 months after enrollment)
Change in stride length	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.	Visit 5 (within 6 months after enrollment)
Change in stride length	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.	Visit 6 (within 6 months after enrollment)
Change in stride length	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.	Visit 7 (within 6 months after enrollment)
Change in stride length	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.	Visit 8 (within 6 months after enrollment)
Change in percent time spent freezing	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.	Visit 9 (within 6 months after enrollment)
Change in stride length	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.	Visit 9 (within 6 months after enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in freezing-of-gait ratio	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.	Visit 4 (within 6 months after enrollment)
Change in freezing-of-gait ratio	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.	Visit 5 (within 6 months after enrollment)
Change in freezing-of-gait ratio	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.	Visit 6 (within 6 months after enrollment)
Change in freezing-of-gait ratio	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.	Visit 7 (within 6 months after enrollment)
Change in freezing-of-gait ratio	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.	Visit 8 (within 6 months after enrollment)
Change in 2-Minute Walk Test Distance	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.	Visit 5 (within 6 months after enrollment)
Change in 2-Minute Walk Test Distance	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.	Visit 6 (within 6 months after enrollment)
Change in 2-Minute Walk Test Distance	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.	Visit 7 (within 6 months after enrollment)
Change in 2-Minute Walk Test Distance	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.	Visit 8 (within 6 months after enrollment)
Change in range of motion	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.	Visit 4 (within 6 months after enrollment)
Change in cadence	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.	Visit 4 (within 6 months after enrollment)
Change in cadence	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.	Visit 5 (within 6 months after enrollment)
Change in cadence	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.	Visit 6 (within 6 months after enrollment)
Change in cadence	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.	Visit 7 (within 6 months after enrollment)
Change in cadence	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.	Visit 8 (within 6 months after enrollment)
Change in stride time variability	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.	Visit 4 (within 6 months after enrollment)
Change in stride time variability	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.	Visit 5 (within 6 months after enrollment)
Change in stride time variability	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.	Visit 6 (within 6 months after enrollment)
Change in stride time variability	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.	Visit 7 (within 6 months after enrollment)
Change in stride time variability	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.	Visit 8 (within 6 months after enrollment)
Change in peak foot-to-floor angle	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.	Visit 4 (within 6 months after enrollment)
Change in freezing-of-gait ratio	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.	Visit 9 (within 6 months after enrollment)
Change in 2-Minute Walk Test Distance	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.	Visit 9 (within 6 months after enrollment)
Change in cadence	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.	Visit 9 (within 6 months after enrollment)
Change in stride time variability	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.	Visit 9 (within 6 months after enrollment)

Collaborators and Investigators

• Sponsor: Harvard Medical School (HMS and HSDM)
• Collaborators: Boston University; Michael J Fox Foundation for Parkinson Research
• Investigators: Principal Investigator: Terry Ellis, PT, PhD, Boston University; Principal Investigator: Conor J Walsh, PhD, Harvard University

Publications and helpful links

General Publications

• Hausdorff JM, Schaafsma JD, Balash Y, Bartels AL, Gurevich T, Giladi N. Impaired regulation of stride variability in Parkinson's disease subjects with freezing of gait. Exp Brain Res. 2003 Mar;149(2):187-94. doi: 10.1007/s00221-002-1354-8. Epub 2003 Jan 22.
• Nieuwboer A, Dom R, De Weerdt W, Desloovere K, Fieuws S, Broens-Kaucsik E. Abnormalities of the spatiotemporal characteristics of gait at the onset of freezing in Parkinson's disease. Mov Disord. 2001 Nov;16(6):1066-75. doi: 10.1002/mds.1206.
• Nutt JG, Bloem BR, Giladi N, Hallett M, Horak FB, Nieuwboer A. Freezing of gait: moving forward on a mysterious clinical phenomenon. Lancet Neurol. 2011 Aug;10(8):734-44. doi: 10.1016/S1474-4422(11)70143-0.
• Plotnik M, Giladi N, Hausdorff JM. Is freezing of gait in Parkinson's disease a result of multiple gait impairments? Implications for treatment. Parkinsons Dis. 2012;2012:459321. doi: 10.1155/2012/459321. Epub 2012 Jan 12.
• Ziegler K, Schroeteler F, Ceballos-Baumann AO, Fietzek UM. A new rating instrument to assess festination and freezing gait in Parkinsonian patients. Mov Disord. 2010 Jun 15;25(8):1012-8. doi: 10.1002/mds.22993.
• Ehgoetz Martens KA, Shine JM, Walton CC, Georgiades MJ, Gilat M, Hall JM, Muller AJ, Szeto JYY, Lewis SJG. Evidence for subtypes of freezing of gait in Parkinson's disease. Mov Disord. 2018 Jul;33(7):1174-1178. doi: 10.1002/mds.27417.
• Nieuwboer A, Giladi N. Characterizing freezing of gait in Parkinson's disease: models of an episodic phenomenon. Mov Disord. 2013 Sep 15;28(11):1509-19. doi: 10.1002/mds.25683.
• Alice N, Fabienne C, Anne-Marie W, Kaat D. Does freezing in Parkinson's disease change limb coordination? A kinematic analysis. J Neurol. 2007 Sep;254(9):1268-77. doi: 10.1007/s00415-006-0514-3. Epub 2007 Apr 2.
• Siviy C, Baker LM, Quinlivan BT, Porciuncula F, Swaminathan K, Awad LN, Walsh CJ. Opportunities and challenges in the development of exoskeletons for locomotor assistance. Nat Biomed Eng. 2023 Apr;7(4):456-472. doi: 10.1038/s41551-022-00984-1. Epub 2022 Dec 22.
• Macht M, Kaussner Y, Moller JC, Stiasny-Kolster K, Eggert KM, Kruger HP, Ellgring H. Predictors of freezing in Parkinson's disease: a survey of 6,620 patients. Mov Disord. 2007 May 15;22(7):953-6. doi: 10.1002/mds.21458.
• Jacobs JV, Nutt JG, Carlson-Kuhta P, Stephens M, Horak FB. Knee trembling during freezing of gait represents multiple anticipatory postural adjustments. Exp Neurol. 2009 Feb;215(2):334-41. doi: 10.1016/j.expneurol.2008.10.019. Epub 2008 Nov 12.
• Mancini M, Shah VV, Stuart S, Curtze C, Horak FB, Safarpour D, Nutt JG. Measuring freezing of gait during daily-life: an open-source, wearable sensors approach. J Neuroeng Rehabil. 2021 Jan 4;18(1):1. doi: 10.1186/s12984-020-00774-3.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Gait; Parkinson Disease; Soft Robotics; Freezing-of-gait; Wearable Robot
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: IRB#24-0986; 024589 (Other Grant/Funding Number: Michael J Fox Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No