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| ID | Type | Description | Link |
|---|---|---|---|
| 024589 | Other Grant/Funding Number | Michael J Fox Foundation |
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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
| Boston University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-visit ambulatory activities with soft robotic apparel | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Apparel | Device | 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. |
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Franchino Porciuncula, EdD, PT, DScPT | Contact | 617-353-7525 | fporciun@bu.edu | |
| Teresa Baker, DPT | Contact | 617-353-7525 | nwendel@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Terry Ellis, PT, PhD | Boston University | Principal Investigator |
| Conor J Walsh, PhD | Harvard University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Science and Engineering Complex | Recruiting | Allston | Massachusetts | 02134 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20310009 | Background | 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. | |
| 30153383 | Background | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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 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 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) |
| 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 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 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 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 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 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 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 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) |
| 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) |
| Boston University Sargent College of Health and Rehabilitation Sciences | Recruiting | Boston | Massachusetts | 02215 | United States |
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| 22288021 | Background | 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. |
| 24132839 | Background | 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. |
| 17401738 | Background | 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. |
| 11748737 | Background | 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. |
| 12610686 | Background | 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. |
| 36550303 | Background | 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. |
| 17377927 | Background | 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. |
| 21777828 | Background | 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. |
| 19061889 | Background | 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. |
| 33397401 | Background | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |