Recruiting

Robotic Apparel

Sponsor:

Harvard Medical School (HMS and HSDM)

Code:

NCT06602544

Conditions

Parkinson Disease (PD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Robotic Apparel

Study Details

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.

Conditions

Parkinson Disease (PD)

Study ID

NCT06602544

Start date

Sep 3, 2024

Status verified date

Jul, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

  • Change in percent time spent freezing [ Time Frame: Visit 4 (within 6 months after enrollment) ]
  • Change in percent time spent freezing [ Time Frame: Visit 5 (within 6 months after enrollment) ]
  • Change in percent time spent freezing [ Time Frame: Visit 6 (within 6 months after enrollment) ]
  • Change in percent time spent freezing [ Time Frame: Visit 7 (within 6 months after enrollment) ]
  • Change in percent time spent freezing [ Time Frame: Visit 8 (within 6 months after enrollment) ]
  • Change in percent time spent freezing [ Time Frame: Visit 9 (within 6 months after enrollment) ]
  • Change in stride length [ Time Frame: Visit 4 (within 6 months after enrollment) ]
  • Change in stride length [ Time Frame: Visit 5 (within 6 months after enrollment) ]
  • Change in stride length [ Time Frame: Visit 6 (within 6 months after enrollment) ]
  • Change in stride length [ Time Frame: Visit 7 (within 6 months after enrollment) ]
  • Change in stride length [ Time Frame: Visit 8 (within 6 months after enrollment) ]
  • Change in stride length [ Time Frame: Visit 9 (within 6 months after enrollment) ]

Central Contacts and Locations

Central contacts

Franchino Porciuncula, EdD, PT, DScPT

617-353-7525fporciun@bu.edu

Locations

Harvard Science and Engineering Complex

Recruiting

Allston, Massachusetts, United States, 02134

Contacts

Principal Investigator:

Conor J Walsh, PhD

Boston University Sargent College of Health and Rehabilitation Sciences

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Terry Ellis, PhD, PT, FAPTA

617-353-7525tellis@bu.edu

Franchino Porciuncula, EdD, PT, DScPT

617-353-7525fporciun@bu.edu

Principal Investigator:

Terry Ellis, PhD, PT, FAPTA

More Information

Sponsor

Harvard Medical School (HMS and HSDM)

Last update posted

Jul 18, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Harvard Medical School (HMS and HSDM) on 2025-07-18.