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?

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.

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.

Is Robotic Apparel generally safe for humans?

Research on wearable robotic devices, like exoskeletons, shows that they can cause skin discomfort, muscle strain, and changes in blood pressure. These issues often arise from pressure and misalignment between the device and the body, highlighting the need for better safety measures. ^{1 2 3 4 5}

How is the Robotic Apparel treatment for Parkinson's Disease different from other treatments?

Robotic Apparel is unique because it is a wearable device that provides physical assistance through soft, inflatable components, helping to improve movement and reduce muscle effort. Unlike traditional treatments, which may involve medication or surgery, this device offers a non-invasive, mechanical approach to support daily activities. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Robotic Apparel for Parkinson's Disease?

Research on similar wearable robotic devices shows they can improve movement and reduce muscle effort in people with movement disorders, like ALS, by providing active support and enhancing functional activity. Additionally, a study on a dynamic fabric orthosis for Parkinson's patients showed improvements in some motor functions, suggesting potential benefits of wearable robotic devices for similar conditions. ^{3 5 6 7 10}

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

I can understand and communicate effectively with the study staff.

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

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

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]

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]

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]

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]

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 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]

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]

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]

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 '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. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Posture classification via wearable strain sensors for neurological rehabilitation. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects and Safety of Wearable Exoskeleton for Robot-Assisted Gait Training: A Retrospective Preliminary Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Restoring arm function with a soft robotic wearable for individuals with amyotrophic lateral sclerosis. [2023]

5. Switzerland 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

An upper body garment with integrated sensors for people with neurological disorders - early development and evaluation. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

A Taxonomy of Ethical, Legal and Social Implications of Wearable Robots: An Expert Perspective. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Assistive Robotics: A Perspective on Current Challenges and Future Trends. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Single limb cable driven wearable robotic device for upper extremity movement support after traumatic brain injury. [2022]