Ankle Exoskeleton for Stroke

AY
KH
Overseen ByKinsey Herrin, MSPO, C/LPO
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Georgia Institute of Technology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a robotic ankle exoskeleton designed to improve walking ability in stroke survivors. Researchers seek to determine if the exoskeleton's new algorithms enhance walking compared to not using the device. It targets individuals who had a stroke at least six months ago, live independently, and can walk unaided. Participants will walk on treadmills and various surfaces to assess the device's effectiveness. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mobility for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team or your doctor.

What prior data suggests that this ankle exoskeleton is safe for stroke patients?

Research has shown that stroke patients generally receive robotic exoskeletons for walking training well. Studies have found that these devices can improve walking speed, balance, and stamina. Strong evidence of serious side effects is lacking, making them a promising recovery option. Most patients have used the exoskeletons without major problems. While some might experience minor discomfort or need time to adjust, the treatment is considered safe based on current data. For those considering joining this type of trial, these findings suggest a positive safety outlook.12345

Why are researchers excited about this trial?

Researchers are excited about the ankle exoskeleton for stroke rehabilitation because it offers a unique, robotic approach to gait assistance. Unlike conventional treatments like physical therapy and ankle-foot orthoses, this exoskeleton provides powered support to the ankle, potentially enhancing mobility and reducing the effort needed for walking. By actively assisting the ankle joint, it could help stroke survivors improve their walking ability more efficiently. This innovative technology aims to complement existing therapies, offering a dynamic and adjustable solution tailored to the individual's needs.

What evidence suggests that this ankle exoskeleton is effective for stroke?

Research has shown that ankle exoskeletons can aid stroke recovery. One study found that a robotic exoskeleton increased walking speed in stroke patients. Another study demonstrated improved joint movement and muscle use with these devices. Wearable robots for walking training also resulted in faster walking and better endurance compared to regular therapy. Overall, these findings suggest that ankle exoskeletons may enhance walking abilities in stroke survivors. Participants in this trial will use the powered ankle exoskeleton to assess its effectiveness in gait assistance for stroke recovery.12346

Who Is on the Research Team?

AY

Aaron Young, PhD

Principal Investigator

Georgia Institute of Technology

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-85 who had a stroke at least 6 months ago, can walk without someone's help (FAC score of 3+), live independently, and can consent to participate. It's not for those who don't fit the exoskeleton, shuffle when walking, need assistance or a walker to walk, or have other severe impairments.

Inclusion Criteria

I am between 18 and 85 years old.
I had a stroke more than 6 months ago.
I feel I can safely do what the study asks of me.
See 3 more

Exclusion Criteria

For exoskeleton-only studies, the exoskeleton device does not fit appropriately or safely, as determined by the research team during the fitting assessment.
I shuffle my feet when I walk.
I need someone's help to walk.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants perform movement tasks without the ankle exoskeleton to establish baseline conditions

4 weeks
Multiple visits for baseline assessment

Treatment

Participants are fitted with an ankle exoskeleton and perform movement tasks to test the new AI algorithms

1 year
Regular visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ankle Exoskeleton
Trial Overview The study tests new control algorithms for an ankle exoskeleton designed to enhance gait in stroke survivors. Participants will use this device while walking on treadmills and during various tasks. Performance with the device will be compared against walking without it.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Ankle exoskeleton for stroke gait assistanceExperimental Treatment2 Interventions

Find a Clinic Near You

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+

Citations

Efficacy of robotic exoskeleton for gait rehabilitation in patients ...These present findings suggest that the use of RAGT associated with CT is effective on gait recovery in subacute stroke patients, albeit not superior at only ...
Interim results of exoskeletal wearable robot for gait ...Overground gait training with a torque-assisted exoskeleton in this study showed improvement in gait function comparable to conventional gait rehabilitation in ...
A wearable ankle-assisted robot for improving gait function ...Overall, our results suggest that a positive change in gait patterns was observed in the RAG condition, with improvements in joint angle, moment ...
Effects of soft robotic exoskeleton for gait training on ...Compared with CR training, SRE-assisted walking training led to greater improvements in walking speed, endurance, and motor recovery.
The Effectiveness of Overground Robot Exoskeleton Gait ...The results of this study indicate that overground robot exoskeleton gait training is effective at improving gait speed in patients with stroke.
Effect of wearable exoskeleton on post-stroke gaitA meta-analysis was conducted to explore the benefits of the wearable exoskeleton on mobility capacity, walking speed, motor function, balance, endurance and ...
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