Exoskeleton for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

Overseen by Mark S Baron, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Neurological, Musculoskeletal, CHF, COPD, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Physical therapy approaches for balance and walking deficits in Parkinson's disease (PD) have limited effectiveness, with mostly short-lasting benefits. An exoskeleton is a device that straps to the legs and provides a passive force to assist people to better ambulate. The goal of this study is to establish the feasibility and safety of a lightweight exoskeleton on mobility and fall reduction in people with PD. As most PD patients eventually require assistive mobility devices, the exoskeleton represents a new option for increased, mobility, quality of life, and independence. Qualified subjects will come to the clinic twice weekly for six weeks (12 total visits) and wear the exoskeleton device while walking under the supervision of a trained physical therapist. Study staff will also interview participants and assess their PD symptoms, quality of life, and overall mobility. This study hopes to establish exoskeletons as modern, standard of care devices, which allow people with PD to maintain more independent and productive lives.

Will I have to stop taking my current medications?

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

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

Research shows that using an exoskeleton for gait training can improve walking distance and reduce the effort needed for people with Parkinson's Disease. Another study found that exoskeleton-assisted training improved arm movement speed and accuracy, suggesting potential benefits for motor skills. ^{1 2 3 4 5}

What safety information is available for exoskeletons used in medical applications?

Exoskeletons have been approved for use by regulatory bodies like the FDA, but there are still risks such as falls and unintended device motion. Safety measures are being developed to reduce these risks, and current devices are generally used under supervision to ensure user safety. ^{6 7 8 9 10}

How does the exoskeleton treatment for Parkinson's disease differ from other treatments?

The exoskeleton treatment for Parkinson's disease is unique because it uses a wearable robotic device to assist with movement and improve gait, unlike traditional treatments that primarily rely on medication or surgery. This approach offers a non-invasive, mechanical method to enhance mobility and reduce symptoms, potentially increasing exercise endurance and improving daily activities. ^{1 11 12 13 14}

Research Team

Mark S Baron, MD

Principal Investigator

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Eligibility Criteria

This trial is for people with Parkinson's Disease confirmed by a specialist, who can walk at least 20 minutes with an exoskeleton during screening. They should be between stages II-V of the disease and not have severe cognitive issues or other health problems like heart failure or osteoporosis. Participants must be between 5'1" and 6'3" tall, weigh less than 250 pounds, and not have any lower limb amputations.

Inclusion Criteria

You have been diagnosed with Parkinson's disease by a specialist using specific criteria.

My Parkinson's disease is at a moderate to advanced stage.

Exclusion Criteria

I have severe heart failure, severe lung problems, or need oxygen through a nose tube.

I have a feeding tube or a port for feeding.

I have conditions affecting my movement not related to Parkinson's disease.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear the Keeogo exoskeleton device while walking under supervision for 6 weeks

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• Exoskeleton (Procedure)

Trial Overview The study tests if a portable leg-strapped exoskeleton can help improve walking and reduce falls in Parkinson's patients. Participants will use this device under supervision twice weekly for six weeks while their mobility and quality of life are monitored.

Participant Groups

Group I: Feasibility and Safety Experimental Treatment 1 Intervention

This is a feasibility study to assess the safety and potential utility of a lightweight ground exoskeleton (Keeogo, B-Temia, Inc.) to enhance mobility in people with Parkinson's disease (PD).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

Home-based gait training using the Stride Management Assist (SMA) exoskeleton significantly improved walking distance in people with moderately advanced Parkinson's disease, with participants in the SMA group walking an average of 13.7 meters further in a 3-minute test after training.

The SMA group also showed a significant reduction in the physiological cost index, indicating improved walking efficiency, while the control group did not experience any notable changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Wearable Device Gait Training on Parkinson's Disease: A Randomized Controlled Open-label Pilot Study. Kawashima, N., Hasegawa, K., Iijima, M., et al.[2022]

A pilot study involving 20 right-handed patients with Parkinson's disease showed that training with a passive exoskeleton significantly improved upper limb motor performance, particularly in speed and accuracy for both simple and complex movements.

Patients demonstrated notable improvements in their overall motor function as measured by the UPDRS II and III scales after 4 weeks of training, indicating the potential efficacy of high-tech rehabilitation methods for enhancing motor skills in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper Limb Interactive Weightless Technology-Aided Intervention and Assessment Picks Out Motor Skills Improvement in Parkinson's Disease: A Pilot Study. Fundarò, C., Cavalieri, C., Pinna, GD., et al.[2020]

The KINARM exoskeleton robot effectively differentiates Parkinson's Disease (PD) patients from healthy controls by quantifying motor symptoms, showing that PD patients are significantly slower and less accurate in movement tasks compared to controls.

Dopamine replacement therapies (DRTs) significantly improve motor performance in PD patients, as indicated by a reduction in symptom severity scores and correlations with traditional clinical assessments like the UPDRS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated robotics platform with haptic control differentiates subjects with Parkinson's disease from controls and quantifies the motor effects of levodopa. Gaprielian, P., Scott, SH., Lowrey, C., et al.[2020]

Exoskeletons are advanced wearable robots designed to assist individuals with motor disorders, enhancing rehabilitation through close cognitive and physical interaction with users.

Key areas for future development include improving the safety and reliability of human-robot interactions, ensuring the exoskeletons are portable and user-friendly, and addressing user acceptance to maximize their effectiveness in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation exoskeletal robotics. The promise of an emerging field. Pons, JL.[2010]

A telerehabilitation exergaming system using the Kinect sensor was developed and tested with 28 Parkinson's disease patients, showing significant improvements in upper extremity function and daily activities without changing their medication plan.

The study found that while exergaming is feasible for patients, with some achieving clinically meaningful improvements in various tests, technical assistance may be needed for setup and use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can telerehabilitation games lead to functional improvement of upper extremities in individuals with Parkinson's disease? Cikajlo, I., Hukić, A., Dolinšek, I., et al.[2018]

The systematic review of 36 studies (4 in-field and 32 laboratory) on shoulder and back exoskeletons found that the most common side-effect reported was discomfort, affecting 30 participants, along with limited usability in 16 cases.

The review highlighted that many side-effects, such as changes in muscle activity and posture, were often due to incorrect fitting and reduced mobility of the exoskeletons, but overall evidence on adverse events is limited and primarily focused on short-term effects in young male workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side-effects and adverse events of a shoulder- and back-support exoskeleton in workers: A systematic review. Kranenborg, SE., Greve, C., Reneman, MF., et al.[2023]

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

Exoskeleton-assisted walking was found to be feasible and safe for about one-third of the 13 participants with multiple sclerosis, with moderate learnability requiring 5 to 15 sessions to achieve minimal assistance in walking.

While the device showed good safety with manageable adverse events, participants experienced varying levels of satisfaction and some improvements in posture and spasticity, suggesting potential secondary benefits from routine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of a Powered Exoskeleton for Assisted Walking for Persons With Multiple Sclerosis: A Single-Group Preliminary Study. Kozlowski, AJ., Fabian, M., Lad, D., et al.[2018]

The study developed a fall control strategy for powered lower limb exoskeletons (LLEs) that significantly reduces the risk of head injuries and decreases hip impact velocity by over 50% during simulated falls.

By optimizing joint trajectories and torque profiles, the new strategy allows for safer independent use of LLEs, addressing a major safety concern that currently limits their use to supervised settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing safe fall strategies for lower limb exoskeletons. Khalili, M., Borisoff, JF., Van der Loos, HFM.[2018]

A survey conducted among exoskeleton users highlighted the need for a rigorous risk assessment process to ensure the safety and effectiveness of exoskeleton technology, which is rapidly growing in various applications.

Key safety concerns identified include misalignments and unintended device motion, which could significantly impact user safety and should be addressed in future risk assessments and mitigation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relevance of hazards in exoskeleton applications: a survey-based enquiry. Massardi, S., Pinto-Fernandez, D., Babič, J., et al.[2023]

The PDShoe is a new vibratory feedback device designed to help improve gait in individuals with Parkinson's disease by providing adjustable vibratory cues during daily activities.

A preliminary evaluation with four Parkinson's disease patients and two healthy subjects demonstrated the usability of the PDShoe, indicating its potential for enhancing mobility in PD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An untethered shoe with vibratory feedback for improving gait of Parkinson's patients: the PDShoe. Winfree, KN., Pretzer-Aboff, I., Hilgart, D., et al.[2020]

The TuMove wrist exoskeleton effectively dampens essential tremor symptoms, reducing tremor angular velocity by over 30% during tasks like drinking and pouring, based on tests with 5 healthy subjects.

Users experienced significant improvements in dexterity, completing tasks like the Archimedes spiral and the 9-Hole-Peg-Test faster by approximately 13% and 11.8%, respectively, demonstrating the exoskeleton's potential for enhancing daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Damping TENS-Induced Essential Tremor Symptoms in Activities of Daily Living Using the TuMove Wrist Exoskeleton. Garcia-Higuera, JA., Paredes-Acuna, N., Le, T., et al.[2023]

The WOTAS robotic exoskeleton is designed to help suppress tremors in individuals with movement disorders, utilizing innovative control strategies that apply biomechanical loading and notch filtering to reduce tremor effects.

Clinical trials demonstrate the feasibility of using this exoskeleton for ambulatory tremor suppression, suggesting it could be a valuable alternative treatment alongside traditional methods like medication and rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and validation of a rehabilitation robotic exoskeleton for tremor assessment and suppression. Rocon, E., Belda-Lois, JM., Ruiz, AF., et al.[2022]

Assistive devices, such as limb weights and handheld devices, can effectively reduce tremor severity and improve functional performance in patients, offering a safe and low-cost adjunct to current treatments for tremor disorders.

Despite their potential benefits, the adoption of assistive technologies is hindered by concerns about privacy, trust, and functionality, highlighting the need for interdisciplinary evaluation to enhance accessibility and user comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving functional disability in patients with tremor: A clinical perspective of the efficacies, considerations, and challenges of assistive technology. Bhidayasiri, R., Maytharakcheep, S., Phumphid, S., et al.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Efficacy of Wearable Device Gait Training on Parkinson's Disease: A Randomized Controlled Open-label Pilot Study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Upper Limb Interactive Weightless Technology-Aided Intervention and Assessment Picks Out Motor Skills Improvement in Parkinson's Disease: A Pilot Study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Integrated robotics platform with haptic control differentiates subjects with Parkinson's disease from controls and quantifies the motor effects of levodopa. [2020]

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

Rehabilitation exoskeletal robotics. The promise of an emerging field. [2010]

5. England pubmed.ncbi.nlm.nih.gov

Can telerehabilitation games lead to functional improvement of upper extremities in individuals with Parkinson's disease? [2018]

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

Side-effects and adverse events of a shoulder- and back-support exoskeleton in workers: A systematic review. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. [2020]

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

Feasibility and Safety of a Powered Exoskeleton for Assisted Walking for Persons With Multiple Sclerosis: A Single-Group Preliminary Study. [2018]

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

Developing safe fall strategies for lower limb exoskeletons. [2018]

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

Relevance of hazards in exoskeleton applications: a survey-based enquiry. [2023]

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

An untethered shoe with vibratory feedback for improving gait of Parkinson's patients: the PDShoe. [2020]

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

Damping TENS-Induced Essential Tremor Symptoms in Activities of Daily Living Using the TuMove Wrist Exoskeleton. [2023]

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

Design and validation of a rehabilitation robotic exoskeleton for tremor assessment and suppression. [2022]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Improving functional disability in patients with tremor: A clinical perspective of the efficacies, considerations, and challenges of assistive technology. [2022]