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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests robotic exoskeleton devices designed to help stroke survivors walk better. Participants will use two types of exoskeletons: one for the hip (Hip Exoskeleton) and one for the ankle (Ankle Exoskeleton), to determine which improves walking in real-world settings. The trial focuses on finding a personalized fit that aids movement without hindering it. It may suit individuals who had a stroke at least six months ago, can walk independently without a walker, and live on their own. As an unphased trial, this study offers a unique opportunity to explore innovative technology that could enhance mobility and independence.

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 prior data suggests that this exoskeleton device is safe for post-stroke gait improvement?

Research has shown that exoskeleton devices for the ankle and hip can improve walking after a stroke. Studies have found that ankle exoskeletons assist with hemiplegic gait, a common walking difficulty post-stroke. These devices are generally easy to use and often enhance joint movement and balance.

For hip exoskeletons, research suggests they can increase walking speed, endurance, and balance. They are usually safe and effective for stroke recovery, and users often notice improved walking abilities after training with these devices.

Both ankle and hip exoskeletons prioritize safety, and current findings support their use in rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exoskeleton assistance for stroke survivors because it offers a novel way to improve walking ability. Unlike traditional rehabilitation therapies that rely on physical exercises and manual assistance, exoskeletons provide mechanical support directly to the joints, specifically the ankle and hip. This technology can enhance mobility by allowing more natural and efficient movements, potentially reducing the energy expenditure required for walking. By integrating advanced mechanics with rehabilitation, exoskeletons might offer faster and more measurable improvements in gait for stroke survivors.

What evidence suggests that these exoskeleton devices are effective for improving post-stroke gait?

This trial will compare the effectiveness of two types of exoskeletons for post-stroke gait improvement: the Ankle Exoskeleton and the Hip Exoskeleton. Research has shown that wearable ankle robots can help stroke survivors walk better, proving more effective than regular walking exercises in increasing speed and stability. Studies have found that these devices can adjust the assistance they provide based on the user's gait, making them highly adaptable.

For hip exoskeletons, research indicates they can enhance walking speed and stamina in stroke survivors. Users of these devices have demonstrated improvements in balance and overall movement. Both ankle and hip exoskeletons offer powered support, making walking easier and more effective for stroke survivors. Participants in this trial will use both types of exoskeletons in separate sessions to assess their effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

Aaron Young, PhD

Principal Investigator

Georgia Institute of Technology

Greg Sawicki

Principal Investigator

Georgia Institute of Technology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6700322/

Wearable Ankle Robots in Post-stroke Rehabilitation of Gait Preliminary findings suggest that wearable ankle robots have certain clinical benefits for the treatment of hemiplegic gait post-stroke.

2. arxiv.org arxiv.org/html/2508.00691v2

[This is a preprint - Accepted for publication at IROS 2025 ... Results on the data of four people post stroke demonstrate the validity for assistance, which is adaptive to individual kinematic and speed ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1877065722000471

Effect of wearable exoskeleton on post-stroke gait Exoskeleton-assisted training was superior to dose-matched conventional gait training in several gait-related outcomes at the end of the intervention and follow ...

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01624-w

A wearable ankle-assisted robot for improving gait function ... A newly developed wearable ankle-assist robot, the GEMS-A, is a potentially useful walking assist device for improving gait function and pattern in stroke ...

5. jptrs.org jptrs.org/journal/view.html?doi=10.14474/ptrs.2022.11.4.471

Effect of Robot-Assisted Wearable Exoskeleton on Gait ... Conclusions: This study concluded that a wearable exoskeleton was more effective than conventional gait training in improving the gait speed in ...

6. arxiv.org arxiv.org/html/2508.00691v1

Accepted for publication at IROS 2025] Towards Data ... The exoskeleton used for this study (Figure 1.B) is a previously developed portable, rigid ankle exoskeleton designed to assist post-stroke ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9733705/

Post-stroke rehabilitation of the ankle joint with a low cost ... Discussion and significance: Device usability and patient safety were tested. Patients improved joint range and monopodal balance. The MEXO exoskeleton might be ...