Powered Hip Exoskeleton for Severe Lung Disease

Overseen By Tom Dolmage

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Park Healthcare Centre

Disqualifiers: Cardiac issues, Hypertension, Neoplasia, others

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

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a powered hip exoskeleton designed to help people with severe lung disease walk more easily. The device functions like a wearable robot, supporting the legs to make walking less tiring and enabling faster and longer distances. Researchers aim to determine if this exoskeleton can improve walking endurance for individuals who experience breathing difficulties while walking. Candidates with stable chronic respiratory disease and frequent shortness of breath during daily activities may be suitable for participation. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance mobility for those facing respiratory challenges.

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 prior data suggests that this powered hip exoskeleton is safe for individuals with severe lung disease?

Research shows that hip exoskeletons can help people move better and walk faster, especially after a stroke. However, the safety of these devices remains under investigation. Some studies have explored their use in various situations, but all possible risks are not yet known.

This trial is in an early stage, focusing on assessing the exoskeleton's safety. While there is potential, complete safety information is not yet available. Participants should consider this when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the powered hip exoskeleton because it's a novel approach to helping people with severe lung disease. Unlike traditional treatments that focus on medications or breathing exercises, this wearable robot assists with movement, reducing the energy needed for walking. It features sensors and motors that align with the user's natural body movements, providing support and potentially improving mobility and endurance. This innovative technology could mean more independence and a better quality of life for patients.

What evidence suggests that this exoskeleton is effective for severe lung disease?

Research shows that powered hip exoskeletons, which participants in this trial will use, can help people with long-term health issues move better. Studies have found that people with chronic respiratory disease (CRD) walk longer and more comfortably when using these exoskeletons. The exoskeletons assist by taking on some of the effort needed for walking, making it easier for the user. This reduces the strain on their breathing, allowing them to walk faster and cover more distance. Overall, powered hip exoskeletons offer promising support for improving walking endurance in those with CRD. ^{1 2 3 6 7}

Who Is on the Research Team?

Roger Goldstein, MD, FRCPC

Principal Investigator

West Park Healthcare Centre

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Hip Exoskeleton
• Powered Assist Hip 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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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Keeogo is a lower-extremity powered exoskeleton that may be a potential solution for enabling people with MS to benefit from physical activity and exercise.