Robotic Apparel for Parkinson's Disease

(XF Trial)

Recruiting at 1 trial location

Overseen By Teresa Baker, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Medical School (HMS and HSDM)

Disqualifiers: Cardiovascular, Neurological, Skin, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with Parkinson's Disease who experience freezing of gait, a sensation where their feet feel stuck to the floor. The researchers are testing soft robotic clothing (also known as robotic apparel) that gently aids walking, with the goal of preventing these freezing episodes. The trial seeks participants who experience freezing of gait due to Parkinson's and can walk independently for at least 20 meters. Participants will use this robotic apparel during various walking activities to determine if it improves their ability to move smoothly. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mobility for those with Parkinson's.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this robotic apparel is safe for use in Parkinson's Disease patients?

Research shows that soft robotic clothing can help people with Parkinson's disease walk more easily. In studies, this wearable device has shown promise in preventing "freezing of gait" (FoG), where a person's feet feel stuck to the ground. For example, one study found that the robotic clothing reduced the time spent freezing compared to walking without assistance.

Specific safety data from these studies aren't available. However, testing this wearable technology in clinical settings suggests it is considered safe enough for human trials. The trial's "Not Applicable" phase label indicates it isn't for a new drug or invasive device, often suggesting a safer profile. Additionally, the focus on soft, wearable technology aims to provide gentle assistance, reducing the chance of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Parkinson's disease focus on managing symptoms with medications like levodopa or dopamine agonists. However, robotic apparel offers a novel approach by providing physical assistance to improve mobility. Unlike traditional therapies that rely on chemical interventions, this wearable technology directly supports movement, helping users navigate challenges like freezing-of-gait. Researchers are excited about this innovative method because it could enhance quality of life by reducing reliance on medication and offering a non-invasive option to improve everyday activities.

What evidence suggests that this robotic apparel is effective for freezing-of-gait in Parkinson's disease?

Research has shown that soft robotic clothing, which participants in this trial will use, can help people with Parkinson's disease walk better by gently supporting their hips. Studies have demonstrated that this wearable device improves leg swing, making walking smoother and reducing freezing episodes. Some patients reported that the robotic clothing completely stopped these episodes. By promoting longer and more consistent steps, the robotic clothing helps individuals walk more regularly. This suggests that robotic clothing could be a promising tool to prevent freezing and make walking safer and more reliable for those with Parkinson's disease. ^{1 2 3 4 6}

Who Is on the Research Team?

Terry Ellis, PT, PhD

Principal Investigator

Boston University

Conor J Walsh, PhD

Principal Investigator

Harvard University

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who experience freezing-of-gait (FoG), a condition where they feel like their feet are stuck to the floor while walking. The study aims to help those who face this challenge, which can lead to falls and hospitalization.

Inclusion Criteria

Provide HIPAA Authorization for communication with treating physician/provider for medical clearance if necessary

I can understand and communicate effectively with the study staff.

I experience sudden stops when I walk because of Parkinson's Disease.

Exclusion Criteria

Serious co-morbidities unrelated to gait impairment that may interfere with research participation

I have difficulty walking because I am missing a limb.

I have chronic pain that affects my ability to walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in ambulatory activities with and without the assistance of robotic apparel across multiple visits under various freezing-of-gait provoking scenarios

6 months

8 visits (in-person)

Follow-up

Participants are monitored for changes in gait parameters and freezing-of-gait prevention effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Apparel

Trial Overview The study is testing robotic apparel designed to assist with walking by improving stride length and reducing variability in stride time. This wearable technology provides low force mechanical assistance autonomously, aiming to prevent FoG without overloading cognitive systems.

How Is the Trial Designed?

Group I: Multi-visit ambulatory activities with soft robotic apparel Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Harvard Medical School (HMS and HSDM)

Lead Sponsor

Trials

208

Recruited

1,421,000+

Michael J Fox Foundation for Parkinson Research

Collaborator

Trials

1

Recruited

20+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Published Research Related to This Trial

A lightweight, portable, textile-based robotic wearable for shoulder elevation was tested on 10 individuals with amyotrophic lateral sclerosis (ALS), showing immediate improvements in their active range of motion.

The device not only enhanced functional activity without requiring prior training but also reduced shoulder muscle activity and perceived exertion, suggesting it can help manage muscular fatigue in ALS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoring arm function with a soft robotic wearable for individuals with amyotrophic lateral sclerosis. Proietti, T., O'Neill, C., Gerez, L., et al.[2023]

Wearable assistive robotics can significantly enhance the quality of life for individuals with sensorimotor impairments by enabling them to perform daily activities independently and remain socially active.

The development of these robotic systems involves addressing various challenges, including safety, usability, and adaptability, while incorporating advanced technologies like machine learning and multimodal sensing to ensure effective assistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Assistive Robotics: A Perspective on Current Challenges and Future Trends. Martinez-Hernandez, U., Metcalfe, B., Assaf, T., et al.[2023]

The soft wearable robot designed for assisting forearm movements significantly reduced the effort required by users with movement disorders by an average of 14% during dynamic tasks, showcasing its potential efficacy in enhancing independence.

The innovative control scheme of the robot is based on the equilibrium-point hypothesis, allowing it to effectively integrate user feedback and improve human-robot interaction, which is crucial for the development of safe and comfortable assistive devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assisting Forearm Function in Children With Movement Disorders via A Soft Wearable Robot With Equilibrium-Point Control. Realmuto, J., Sanger, TD.[2022]

In a study of 28 patients with neurological deficits, overground robot-assisted gait training (RAGT) significantly improved muscle strength, balance, and gait function after more than ten sessions, indicating its effectiveness in rehabilitation.

The training was found to be safe, with only two mild adverse events reported, suggesting that RAGT can be a reliable option for patients recovering from neurological injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and Safety of Wearable Exoskeleton for Robot-Assisted Gait Training: A Retrospective Preliminary Study. Park, GM., Cho, SH., Hong, JT., et al.[2023]

Conductive elastomers embedded in garments can effectively monitor rehabilitation exercises for stroke recovery by measuring strain at multiple points, offering a novel solution to current motion-sensing technology limitations.

The use of supervised learning techniques allows for real-time feedback on upper-limb posture during exercises, enhancing the effectiveness of motor rehabilitation at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posture classification via wearable strain sensors for neurological rehabilitation. Giorgino, T., Lorussi, F., De Rossi, D., et al.[2020]

Wearable robots and exoskeletons, designed to assist human movement, raise unique ethical, legal, and social issues that have not been thoroughly examined in existing literature.

The paper categorizes these issues into three main areas: the impact of wearable robots on individual identity ('the self'), their effects on interpersonal relationships ('the other'), and their broader implications for society.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Taxonomy of Ethical, Legal and Social Implications of Wearable Robots: An Expert Perspective. Kapeller, A., Felzmann, H., Fosch-Villaronga, E., et al.[2021]

A novel wearable garment with integrated sensors was developed for continuous monitoring of physiological and movement-related variables, showing promise for improving diagnosis and treatment in conditions like epilepsy, Parkinson's disease, and stroke.

User feedback indicated that while the garment was well-accepted for its design and comfort, technical improvements are necessary, particularly for heart rate monitoring, which was affected by motion artifacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An upper body garment with integrated sensors for people with neurological disorders - early development and evaluation. Alt Murphy, M., Bergquist, F., Hagström, B., et al.[2022]

The dynamic elastomeric fabric orthosis (DEFO) improved certain upper limb motor functions in 40 Parkinson's disease patients over a two-month period, particularly in aspects like rest tremor and movement amplitude.

However, these improvements in motor function did not lead to significant changes in overall functional ability or quality of life as measured by standard scales like the UPDRS and PD quality-of-life questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functionality and Quality of Life with Parkinson's Disease after Use of a Dynamic Upper Limb Orthosis: A Pilot Study. Jiménez-Barrios, M., González-Bernal, J., Cubo, E., et al.[2023]

A systematic review of 50 studies involving 985 subjects revealed that adverse events (AEs) occurred in 18 studies, with over 169 device-related AEs reported, primarily soft tissue injuries and musculoskeletal issues, particularly in end-effector and exoskeleton devices.

The most common risks associated with stationary robot-assisted gait training include excessive pressure and shear at the interface between the device and the user, as well as misalignments that increase forces on the musculoskeletal system, highlighting the need for improved reporting and safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. Bessler, J., Prange-Lasonder, GB., Schulte, RV., et al.[2021]

The 'Armstrong' wearable robotic device successfully assisted individuals with hemiparesis after traumatic brain injury (TBI) in performing various arm movements, showing improvements in movement trajectory and velocity during testing with two TBI subjects and two healthy individuals.

The study indicates that Armstrong is safe and feasible for upper extremity movement assistance under therapist supervision, highlighting its potential as a rehabilitation tool for those with upper limb impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single limb cable driven wearable robotic device for upper extremity movement support after traumatic brain injury. Kadivar, Z., Beck, CE., Rovekamp, RN., et al.[2022]

Citations

1. nature.com nature.com/articles/s44222-024-00157-6

Soft robotic apparel improves walking in Parkinson's disease The soft robotic apparel delivers bilateral assistive hip flexion torques and aids the forward swing of the leg during the swing phase of walking.

2. wyss.harvard.edu wyss.harvard.edu/news/soft-robotic-wearable-device-improves-walking-for-individual-with-parkinsons-disease/

Soft robotic, wearable device improves walking for ... Soft robotic, wearable device improves walking for individual with Parkinson's disease · Robotic exosuit eliminated gait freezing, a common and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06602544?term=Michael%20Walsh&viewType=Table&rank=1

Robotic Apparel to Prevent Freezing of Gait in Parkinson ... We hypothesize that robotic apparel will be effective in preventing FoG, compared to unassisted walking, as evidenced by lower percent time spent freezing and ...

4. michaeljfox.org michaeljfox.org/grant/use-soft-robotic-apparel-prevent-freezing-gait-parkinsons-disease

Use of Soft Robotic Apparel to Prevent Freezing of Gait in ... We will examine the potential of an intervention that involves the use of wearable, soft robotic apparel to improve walking and prevent FoG in people with PD.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12214301/

Soft Robotics for Parkinson's Disease Supported by ... This article explores the potential of next-generation soft robotics, specifically hydrogel materials, integrated with artificial intelligence (AI) and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38182783/

Soft robotic apparel to avert freezing of gait in Parkinson's ... This study demonstrated that FoG was averted using soft robotic apparel in an individual with Parkinson's disease.