RecruitingNCT06602544XFUpdated Jul 18, 2025

Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

An interventional study of Robotic Apparel in Parkinson Disease (PD), sponsored by Harvard Medical School (HMS and HSDM). Recruiting at 2 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-07-18.

Sponsored by Harvard Medical School (HMS and HSDM) · Not applicable, Interventional, and Treatment

From the registry’s dates

Started Sep 2024; still recruiting 2 years 1 month later.

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 18 Years to 90 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Parkinson Disease (PD)

Browse trials for

Parkinson Disease 4,487

Keywords

Parkinson Disease
Freezing-of-gait
Wearable Robot
Soft Robotics
Gait
Rehabilitation

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Harvard Medical School (HMS and HSDM) is the lead sponsor of 53 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (estimated)

Study arms

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

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.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Visit 9 (within 6 months after enrollment)

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Visit 4 (within 6 months after enrollment)

Study locations

2 of 2 sites recruiting

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

References and documents

Publications

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. PubMed 20310009 ↗
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. PubMed 30153383 ↗
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. PubMed 22288021 ↗
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. PubMed 24132839 ↗
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. PubMed 17401738 ↗
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. PubMed 11748737 ↗
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. PubMed 12610686 ↗
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. PubMed 36550303 ↗
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. PubMed 17377927 ↗
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. PubMed 21777828 ↗
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. PubMed 19061889 ↗
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. PubMed 33397401 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06602544
Lead sponsor: Harvard Medical School (HMS and HSDM)
Collaborators: Michael J. Fox Foundation for Parkinson's Research, Boston University
Responsible party: Conor Walsh (Professor, Harvard Medical School (HMS and HSDM)) — Principal investigator
First posted: Sep 19, 2024
Start date: Sep 3, 2024
Primary completion: Sep 2027 (estimated)
Completion: Sep 2027 (estimated)
Last update: Jul 18, 2025

Study contacts

Franchino Porciuncula, EdD, PT, DScPT

Contact

fporciun@bu.edu

617-353-7525

Teresa Baker, DPT

Contact

nwendel@bu.edu

617-353-7525

Terry Ellis, PT, PhD

principal investigator · Boston University

Conor J Walsh, PhD

principal investigator · Harvard University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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