Hip Exoskeleton Assistance for Stroke Recovery

Overseen By Abbas Alili

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: North Carolina State University

Disqualifiers: Stroke, Pacemaker, Pregnancy, Diabetes, others

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

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Robotic lower limb exoskeletons aim to improve or augment limb functions. Automatic modulation of robotic assistance is very important because it can increase the assistive outcomes and guarantee safety when using exoskeletons. However, this automatic assistance adjustment is challenging due to person-to-person and day-to-day variations, as well as the time-varying complex human-machine-interaction forces. In recent years, human-in-the-loop optimization methods have been investigated to reduce participants' metabolic costs by providing personalized assistance from robotic exoskeletons. However, metabolic cost measure is noisy and the experimental protocol is usually relatively long. In addition, the influence of exoskeleton control on this human state in terms of energetic cost is unclear and indirect. More importantly, the optimization by reducing metabolic cost is found to affect human gait patterns and cause undesired outcomes. In this study, new evaluation measures other than metabolic cost will be investigated to optimize the assistance from a powered hip exoskeleton based on a reinforcement learning method. It is hypothesized that the new reinforcement learning-based optimal control approach will produce personalized torque assistance, reduce human volitional effort, and improve balance and other performance during walking tasks. Both participants without and with neurological disorders will be included in this study.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you use an electronically controlled medical device or have uncontrolled diabetes, you may not be eligible to participate.

What data supports the effectiveness of the treatment Hip Exoskeleton, Powered Assist Hip Exoskeleton, Keeogo powered exoskeleton for stroke recovery?

Research shows that powered hip exoskeletons can improve walking speed and endurance in stroke survivors, with some individuals experiencing better motor control and postural stability. The Keeogo™ dermoskeleton, specifically, has been shown to enhance walking performance and daily activity participation in people with moderate mobility impairments due to neurological conditions. ^{1 2 3 4 5}

Is the hip exoskeleton generally safe for human use?

The safety of hip exoskeletons, including the Keeogo powered exoskeleton, is still being studied. Some risks have been identified, such as misalignments and unintended device motion, but with proper risk management and improvements, these devices may become safer for users. ^{1 4 6 7 8}

How does the hip exoskeleton treatment differ from other treatments for stroke recovery?

The hip exoskeleton treatment is unique because it uses a wearable robotic device to assist with hip movement, potentially improving walking speed and gait symmetry for stroke survivors. Unlike traditional therapies, this technology offers powered assistance, which may provide additional benefits, especially for those in the sub-acute phase of stroke recovery. ^{1 2 3 9 10}

Eligibility Criteria

This trial is for adults aged 18-64 living in the US who can walk unassisted and have full hip movement. They must understand the study and agree to participate. It's not clear who can't join because exclusion criteria are missing.

Inclusion Criteria

I have had a stroke in the last 6 months causing weakness on one side.

I can walk unaided for 6 minutes or more, covering at least 1000 feet.

My vision and hearing are normal or corrected to be normal.

Exclusion Criteria

I have difficulty understanding or following instructions due to cognitive or language issues.

I do not have unmanaged heart, blood, metabolic, or cognitive conditions.

You have any skin-related allergies or irritation to adhesives

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo sessions with the hip exoskeleton to optimize assistance and improve walking functions

8 weeks

Up to 5 sessions, each lasting no longer than 4 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Hip Exoskeleton

Trial Overview The study tests a wearable bilateral hip exoskeleton with three modes: zero impedance, personalized optimal assistance, and free walking without the device. The goal is to improve balance and reduce effort during walking by using new control methods.

Participant Groups

Group I: Group B - Participants with paretic stroke Experimental Treatment 3 Interventions

Individuals with paretic stroke will be recruited (Group S). Usually, participants from this group have limited hip joint motion of range, weakened hip joint flexion or extension, or both flexion and extension functionalities, but they can also walk independently.

Group II: Group A - Participants without neurological disorders Experimental Treatment 3 Interventions

Individuals without any neurological disorders will be recruited (Group A). Usually, participants from this group are able to walk normally on different terrains and at multiple typical walking speeds.

Who Is Running the Clinical Trial?

North Carolina State University

Lead Sponsor

Trials

38

Recruited

50,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Findings from Research

A study involving nine ambulatory stroke survivors tested a novel hip exoskeleton, but no significant differences were found in functional outcomes like speed or gait symmetry compared to baseline conditions.

Some participants reported improved perceived walking ability outdoors with the exoskeleton, suggesting potential benefits for certain individuals, but concerns about the device's weight and assistance highlight the need for further development in hip exoskeleton technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards meaningful community ambulation in individuals post stroke through use of a smart hip exoskeleton: a preliminary investigation. Herrin, K., Upton, E., Young, A.[2023]

Powered robotic exoskeletons are a safe intervention for gait rehabilitation in stroke patients, showing meaningful improvements in walking outcomes, especially in those who are in the sub-acute phase of recovery.

While exoskeleton training is equivalent to traditional therapy for chronic stroke patients, sub-acute patients may benefit more from this technology, indicating a need for further rigorous trials to establish its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. Louie, DR., Eng, JJ.[2023]

Powered hip exoskeletons significantly improved walking speed in stroke patients, with a 17.6% increase using bilateral assistance and an 11.1% increase with unilateral assistance, compared to walking without a device.

Both assistance strategies also enhanced step length for both the affected and unaffected legs, indicating that exoskeletons can effectively improve gait biomechanics and overall mobility post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Bilateral Assistance for Hemiparetic Gait Post-Stroke Using a Powered Hip Exoskeleton. Pan, YT., Kang, I., Joh, J., et al.[2023]

Individuals with moderate mobility impairments (Berg Balance Scale scores of 46-51 and Timed Up and Go times of 8-12 seconds) are most likely to benefit from using the Keeogo™ dermoskeleton, as identified in a study of 13 participants with neurological impairments.

Wearing the Keeogo™ dermoskeleton significantly improved performance in various mobility tests, including the 30-second chair stand and stair climb tests, enhancing motor control, postural stability, and overall movement kinetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Keeogo™ Dermoskeleton. Mcleod, JC., Ward, SJ., Hicks, AL.[2020]

Lower limb exoskeletons like ReWalk™, Mina, and Indego® have shown effectiveness for walking in controlled laboratory settings for individuals with paraplegia, but their long-term applicability and effectiveness in real-world community settings remain unproven.

The ReWalk™ exoskeleton demonstrated the best walking performance, achieving a maximum speed of 0.51 m/s after 45 sessions, but overall evidence supporting the use of these devices is low, indicating a need for further research on their long-term benefits compared to traditional mobility aids like wheelchairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exoskeletons' design and usefulness evidence according to a systematic review of lower limb exoskeletons used for functional mobility by people with spinal cord injury. Lajeunesse, V., Vincent, C., Routhier, F., et al.[2018]

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 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 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]

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]

The Hybrid Assistive Limb (HAL) robot suit significantly improved the forward-tilt angle during the sit-to-stand (STS) movement in stroke patients, increasing from an average of 35° without HAL to 43° with HAL assistance.

While the time taken to perform the STS movement increased with HAL use (from 3.42 seconds to 5.11 seconds), the integrated EMG readings indicated that HAL effectively engaged the vastus medialis muscle, suggesting it may enhance muscle activity during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a hybrid assistive limb(®) on sit-to-stand and standing patterns of stroke patients. Kasai, R., Takeda, S.[2020]

References

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

Towards meaningful community ambulation in individuals post stroke through use of a smart hip exoskeleton: a preliminary investigation. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. [2023]

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

Effects of Bilateral Assistance for Hemiparetic Gait Post-Stroke Using a Powered Hip Exoskeleton. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of the Keeogo™ Dermoskeleton. [2020]

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

Exoskeletons' design and usefulness evidence according to a systematic review of lower limb exoskeletons used for functional mobility by people with spinal cord injury. [2018]

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

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

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

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

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

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

9. 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]

10. Japan pubmed.ncbi.nlm.nih.gov

The effect of a hybrid assistive limb(®) on sit-to-stand and standing patterns of stroke patients. [2020]