Exoskeleton Assistance for Post-Stroke Gait Improvement

Overseen By Greg Sawicki, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgia Institute of Technology

Disqualifiers: Loss of leg sensation, Spinal injury, Cardiovascular conditions, Neurological disorders, others

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

What is the purpose of this trial?

An exoskeleton device is a robotic system designed to improve an individual's ability to move and perform tasks encountered in everyday situations. These devices consist of external rigid limb segments that assists humans through different body movements with the use of actuators. These devices are controlled by an onboard computer that determines the timing and magnitude of assistance deployed to the user. Exoskeleton controller performance is key to providing beneficial assistance that does not inhibit the user's movement. Preceding work will compare the benefit of personalized hip versus ankle joint exoskeleton assistance for improvement of post-stroke gait. It will combine exoskeleton technology with the user's movement feedback to improve wearable robotic assistance to an individual stroke survivor's gait pattern. For the clinical trial research covered under this protocol, the investigator will test various exoskeleton technologies with stroke survivors in real-world contexts, indoors and outdoors, and measure clinically meaningful outcomes and user perceptions regarding technology usability and adoption. The long-term goal is to deploy self-adaptive, adoptable exoskeletons for personalized assistance during community ambulation.

Do I need to stop my current medications for the trial?

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 treatment Ankle Exoskeleton, Wearable Ankle Exoskeleton, Ankle Exoskeleton Assistance Device, Hip Exoskeleton, Powered Assist Hip Exoskeleton, Keeogo powered exoskeleton for post-stroke gait improvement?

Research shows that wearable ankle robots and powered hip exoskeletons can improve walking speed and gait function in stroke survivors. Studies found that these devices help enhance ankle movement and walking speed, suggesting they may be beneficial for post-stroke rehabilitation. ^{1 2 3 4 5}

Is the use of exoskeletons for gait improvement generally safe for humans?

Clinical trials suggest that powered robotic exoskeletons can be used safely as a gait training intervention for stroke patients. However, the regulatory science is still developing, and there is a need for more comprehensive reporting of adverse events and risk mitigation strategies to ensure safety. ^{1 2 6 7 8}

How does the Ankle and Hip Exoskeleton treatment differ from other treatments for post-stroke gait improvement?

The Ankle and Hip Exoskeleton treatment is unique because it uses wearable technology to provide powered assistance to the hip and ankle, improving walking speed and gait symmetry in stroke patients. Unlike traditional physiotherapy, this treatment offers targeted, mechanical support to enhance mobility and potentially improve neural recovery through repetitive walking practice. ^{1 3 4 5 9}

Research Team

Aaron Young, PhD

Principal Investigator

Georgia Institute of Technology

Greg Sawicki

Principal Investigator

Georgia Institute of Technology

Eligibility Criteria

This trial is for chronic stroke survivors aged 18-85 who can walk at least a little bit and have been living with the condition for over six months. They should be able to sit without help, transfer from sitting to standing, handle small slopes and steps, and commit to a few hours of testing with breaks.

Inclusion Criteria

I can walk for at least 6 minutes without stopping.

I had a stroke more than 6 months ago.

I can sit without support for at least 30 seconds.

Exclusion Criteria

I have a complete spinal cord injury.

I have severe heart issues or joint problems that restrict my leg movement.

I have a neurological disorder like Parkinson's, ALS, MS, or dementia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acclimation and Testing

Participants acclimate to the exoskeleton device and undergo various walking tests both indoors and outdoors, including a 10 meter walk test and a 6-minute walk test.

2 sessions over 2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing, including assessments of perceived exertion and physiological cost index.

2 weeks

Treatment Details

Interventions

• Ankle Exoskeleton
• Hip Exoskeleton

Trial Overview The study tests how well different exoskeleton devices assist walking in real-world settings. Participants will try out robotic systems that support either the hip or ankle during movement, aiming to improve their gait after a stroke.

Participant Groups

Group I: Stroke Survivors Experimental Treatment 3 Interventions

This study will be divided into 2 sessions that will occur on 2 separate days: 1) Hip Exoskeleton session and 2) Ankle Exoskeleton session. In each session, subjects will undergo two conditions in which they complete the outcomes measures 1) while wearing the exoskeleton and 2) in a baseline condition without the exoskeleton. Order of condition and session will be randomized. Prior to the exoskeleton condition, subjects will be allowed time to acclimate to the device during a walking session on the treadmill. Subjects will complete several timed walking tests both indoors and outdoors. Measurements of energy expenditure may also be recorded along with patient reported outcomes data to assess participant perception of their performance with and without the devices.

Ankle Exoskeleton is already approved in United States for the following indications:

Approved in United States as Ankle Exoskeleton for:

• Mobility assistance for individuals with cerebral palsy

Who Is Running the Clinical Trial?

Georgia Institute of Technology

Lead Sponsor

Trials

53

Recruited

5,600+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Wearable ankle robots show promise in improving gait rehabilitation for stroke survivors, with 97 participants demonstrating enhanced peak dorsiflexion, propulsion on the affected side, and increased walking speed after training.

The study highlights the effectiveness of mixed sensing technology in detecting motion intention, but emphasizes the need for more comparative trials and multicenter randomized controlled trials to further validate the clinical benefits of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Ankle Robots in Post-stroke Rehabilitation of Gait: A Systematic Review. Shi, B., Chen, X., Yue, Z., et al.[2020]

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]

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]

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]

In a study involving sub-acute stroke survivors, integrating robot-assisted gait training with conventional training significantly improved gait recovery, with the swing-controlled ankle robot (SCAR) leading to a higher percentage of independent walkers (56%) compared to conventional training alone (29%).

The power-assisted ankle robot (PAAR) was found to enhance walking speed more effectively than SCAR, indicating that active powered assistance can help users walk faster and more efficiently with their affected leg during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of wearable ankle robotics for stair and over-ground training on sub-acute stroke: a randomized controlled trial. Yeung, LF., Lau, CCY., Lai, CWK., et al.[2021]

The Gait Enhancing and Motivating System-Hip (GEMS-H) significantly improved cortical activation patterns in chronic stroke patients during treadmill walking, promoting more symmetrical activation in the brain's sensorimotor cortex compared to walking without assistance.

Using GEMS-H resulted in reduced oxygenated hemoglobin levels in the late phase of walking, suggesting that it helps streamline gait by facilitating rhythmic hip movements, which may enhance overall gait efficiency and coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable hip-assist robot modulates cortical activation during gait in stroke patients: a functional near-infrared spectroscopy study. Lee, SH., Lee, HJ., Shim, Y., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

G-Exos: A wearable gait exoskeleton for walk assistance. [2022]

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

Wearable Ankle Robots in Post-stroke Rehabilitation of Gait: A Systematic Review. [2020]

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

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

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

Design of a minimally constraining, passively supported gait training exoskeleton: ALEX II. [2012]

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

Randomized controlled trial of robot-assisted gait training with dorsiflexion assistance on chronic stroke patients wearing ankle-foot-orthosis. [2023]

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

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

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

Effects of wearable ankle robotics for stair and over-ground training on sub-acute stroke: a randomized controlled trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Wearable hip-assist robot modulates cortical activation during gait in stroke patients: a functional near-infrared spectroscopy study. [2021]