Powered Hip Exoskeleton for Severe Lung Disease

Overseen by Roger Goldstein, MD, FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: West Park Healthcare Centre

Disqualifiers: Cardiac issues, Hypertension, Neoplasia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Chronic respiratory disease (CRD) is among the most prevalent and growing diseases worldwide with disabling consequences. Many with a compromised respiratory system cannot support the metabolic energy demands of walking causing them to walk slowly and stop often. Those with CRD could receive substantial benefit from a powered wearable exoskeleton device that assumes part of the energy of walking. Assisting the legs will lower the metabolic energy demands, and therefore the ventilation required for exercise, thereby allowing them to walk faster and further. Proposed is a series of single-case experiments comparing walking endurance with and without a powered hip exoskeleton assist. The aim of this study is to determine the efficacy of an exoskeleton on walking endurance in ventilatory limited patients with CRD. An exoskeleton could be a novel immediate and long term strategy to augment walking as part of the spectrum of pulmonary rehabilitation and community reintegration.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have treatments that might influence walk testing, you may be excluded from the trial.

What data supports the effectiveness of the treatment Powered Hip Exoskeleton for Severe Lung Disease?

Research shows that powered exoskeletons like Keeogo can improve mobility and physical function in people with conditions such as multiple sclerosis and knee osteoarthritis. Additionally, wearable hip exoskeletons have been effective in enhancing physical performance and satisfaction in community-living adults, suggesting potential benefits for improving mobility in other conditions. ^{1 2 3 4 5}

Is the powered hip exoskeleton generally safe for humans?

Powered exoskeletons, including those for the hip, have been used in various studies for conditions like multiple sclerosis, knee osteoarthritis, and spinal cord injury. While they show promise in improving mobility and physical function, the safety data is still developing, and potential risks are not fully understood. It's important to have proper risk management and regulatory oversight to ensure safe use. ^{1 2 3 4 6}

How does the powered hip exoskeleton treatment differ from other treatments for severe lung disease?

The powered hip exoskeleton is unique because it provides motorized assistance to help improve mobility and physical function, which is not a typical approach for treating severe lung disease. Unlike traditional treatments that focus on medication or respiratory therapy, this exoskeleton aims to enhance physical activity and quality of life by supporting movement, which could indirectly benefit lung function by promoting overall health. ^{1 2 3 4 7}

Research Team

Roger Goldstein, MD, FRCPC

Principal Investigator

West Park Healthcare Centre

Eligibility Criteria

This trial is for people with stable chronic respiratory disease who experience moderate to severe difficulty breathing during activity. They must fit within the size specifications of the exoskeleton and not have skin issues, heart problems, recent lung surgery or myocardial infarction, untreated cancer, or a high risk of fractures.

Inclusion Criteria

I often feel short of breath when moving around.

My lung condition is stable and not getting worse.

Exclusion Criteria

I have skin sores where the device will be placed.

I have ongoing irregular heartbeats.

You have signs of heart rhythm or circulation problems.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a series of single-case experiments comparing walking endurance with and without a powered hip exoskeleton assist

4 weeks

7 tests (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Hip Exoskeleton (Exoskeleton)
• Powered Assist Hip Exoskeleton (Exoskeleton)

Trial Overview The study tests if a powered hip exoskeleton can help patients with severe lung disease walk faster and longer by reducing the energy needed for walking. Participants will compare their walking endurance with and without this assistive device in single-case experiments.

Participant Groups

Group I: exoskeleton assist Experimental Treatment 1 Intervention

A powered exoskeleton describes a wearable robot designed around the shape and function of the human body with segments and joints externally coupled to those of the user. The exoskeleton includes a belt frame, sensors that detect a user's desired movements, a computerized controller, motors and actuators, and lightweight batteries.

Who Is Running the Clinical Trial?

West Park Healthcare Centre

Lead Sponsor

Trials

36

Recruited

2,400+

Findings from Research

A study involving 29 patients with multiple sclerosis (MS) found that using the Keeogo powered exoskeleton led to significant improvements in unassisted walking endurance and stair climbing ability after two weeks of home use, despite initial performance decrements while wearing the device.

The benefits of Keeogo were linked to how much participants used the device at home, suggesting that it can effectively enhance physical activity and exercise for individuals with mobility impairments due to MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Keeogo exoskeleton for assisting ambulatory activities in people with multiple sclerosis: an open-label, randomized, cross-over trial. McGibbon, CA., Sexton, A., Jayaraman, A., et al.[2020]

The Keeogo™ exoskeleton did not show immediate improvements in physical performance or activity levels in the short term for individuals with knee osteoarthritis, based on a study with 24 participants.

However, over time, users experienced significant cumulative benefits, including improved stair climbing times and reduced pain and stiffness, indicating that the device may enhance long-term mobility and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a lower-extremity robotic exoskeleton for people with knee osteoarthritis. McGibbon, C., Sexton, A., Jayaraman, A., et al.[2022]

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]

A study involving 225 community-living adults showed that using a wearable hip exoskeleton (EX1) for a single 40-minute exercise session significantly improved physical function, including gait speed and performance on tests like the Timed Up and Go (TUG) and Four Square Step Test (FSST).

Participants reported high usability and satisfaction with the EX1, indicating that this technology is not only effective in enhancing physical performance but also well-received by users across different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Improvement and Satisfaction with a Wearable Hip Exoskeleton in Community-Living Adults. Kim, J., Chun, H., Lee, SH., et al.[2023]

In a study involving 14 patients recovering from hip fracture surgery, the HAL lumbar type exoskeleton significantly improved mobility, as shown by a large effect size in the five-times-sit-to-stand test after rehabilitation sessions.

The rehabilitation program using the HAL device was safe, with no adverse events reported, indicating its potential for early postoperative use in enhancing recovery for hip fracture patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Postoperative Rehabilitation Using the Hybrid Assistive Limb (HAL) Lumbar Type in Patients With Hip Fracture: A Pilot Study. Fujikawa, T., Takahashi, S., Shinohara, N., et al.[2022]

A systematic review of 22 studies on powered exoskeletons for individuals with spinal cord injury (SCI) found that most research focuses on patients with thoracic level injuries, particularly T10, and emphasizes gait and ambulation as primary outcome measures.

While powered exoskeletons show promise in improving mobility and health for people with lower-body paralysis, the variability in outcome measures across studies complicates comparisons, highlighting the need for standardized metrics and better patient selection criteria in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Powered exoskeletons for bipedal locomotion after spinal cord injury. Contreras-Vidal, JL., A Bhagat, N., Brantley, J., et al.[2017]

The study involved five post-stroke individuals and six physiotherapists who provided valuable insights after a 1.5-hour session with the H2 exoskeleton, highlighting the importance of user perspectives in the design and functionality of rehabilitation technologies.

Key themes identified included the need for collaboration between developers and users, concerns about device usability, and the potential for exoskeletons to enhance walking ability, indicating a strong interest in this technology for improving post-stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exoskeleton use in post-stroke gait rehabilitation: a qualitative study of the perspectives of persons post-stroke and physiotherapists. Vaughan-Graham, J., Brooks, D., Rose, L., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of the Keeogo exoskeleton for assisting ambulatory activities in people with multiple sclerosis: an open-label, randomized, cross-over trial. [2020]

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

Evaluation of a lower-extremity robotic exoskeleton for people with knee osteoarthritis. [2022]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Functional Improvement and Satisfaction with a Wearable Hip Exoskeleton in Community-Living Adults. [2023]

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

Early Postoperative Rehabilitation Using the Hybrid Assistive Limb (HAL) Lumbar Type in Patients With Hip Fracture: A Pilot Study. [2022]

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

Powered exoskeletons for bipedal locomotion after spinal cord injury. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Exoskeleton use in post-stroke gait rehabilitation: a qualitative study of the perspectives of persons post-stroke and physiotherapists. [2020]