Robotic Exosuit for Stroke Rehabilitation

Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Boston University Charles River Campus
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 tests a new robotic exosuit designed to help people walk better after a stroke. The goal is to determine if the exosuit can improve walking speed and quality by assisting with leg movement. Researchers aim to understand if individuals with varying muscle control patterns respond differently to the exosuit. Participants should be stroke survivors with noticeable walking difficulties, able to walk without support, and fit within certain height and weight limits. As an Early Phase 1 trial, this research focuses on understanding how the exosuit functions in people, offering participants the opportunity to be among the first to experience this innovative technology.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that this robotic exosuit is safe for stroke rehabilitation?

Research has shown that robotic exosuits, used to assist walking after a stroke, are generally safe. Studies have found that these devices can enhance walking speed and strength for stroke survivors. For instance, one study discovered that using an exosuit can reduce the effort needed for walking, making it easier and less tiring.

Although exosuits have been around for a while, this study is in its early stages. Researchers are still collecting initial safety information specific to this trial. However, past research indicates that these devices are usually well-tolerated, with no major safety issues reported. They are designed to aid movement without causing harm or discomfort.

In summary, for those considering joining a trial for robotic exosuit-assisted rehabilitation, existing research supports their safety in improving walking for stroke survivors.12345

Why are researchers excited about this trial?

Researchers are excited about the Robotic Exosuit for stroke rehabilitation because it offers a new way to assist patients during gait training. Unlike traditional physical therapy, which relies on manual support and exercises, this exosuit provides targeted, robotic assistance to the ankle, enhancing walking patterns and potentially speeding up recovery. The exosuit's ability to adapt to the wearer's movements in real-time makes it a promising tool for more personalized and efficient stroke rehabilitation.

What evidence suggests that the robotic exosuit is effective for stroke rehabilitation?

Research has shown that robotic exosuits can greatly help stroke patients walk better. Studies indicate these devices increase walking speed and balance, strengthen the legs, and improve overall quality of life. In this trial, participants will walk without robotic ankle assistance as a comparator. Robotic exosuits ease walking by reducing muscle strain, allowing stroke survivors to move more comfortably. Early results suggest these devices help correct unusual walking patterns, enabling users to walk more normally. These findings highlight the potential of robotic exosuits in stroke recovery.12346

Are You a Good Fit for This Trial?

This trial is for adults who had a stroke at least six months ago and now have trouble walking. They should be able to walk, even if it's not perfect, and they're looking into how robotic ankle support can help improve their gait.

Inclusion Criteria

I have noticeable difficulty walking.
I can walk by myself without help.
I can communicate well and follow instructions.
See 3 more

Exclusion Criteria

Inability to communicate (as assessed by a licensed physical therapist)
Inability to wear the exosuit due to conditions that require medical management, such as open wounds or broken skin, or as assessed by a licensed physical therapist.
I have health conditions other than stroke that affect my ability 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 complete treadmill and overground walking assessments without robotic exosuit assistance

1 week
1 visit (in-person)

Treatment

Participants perform walking trials with robotic exosuit assistance at different assistance onset timings

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Robotic Exosuit-assisted Gait Rehabilitation
Trial Overview The study tests whether wearing a soft robotic exosuit that helps with leg movement can make walking easier or better for stroke survivors. It compares their normal walking to walking with the suit on, using special equipment to measure muscle activity and movements.
How Is the Trial Designed?
1Treatment groups
Active Control
Group I: Walking without robotic ankle assistanceActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials
125
Recruited
14,100+

Citations

Effectiveness of Robot-Assisted Gait Training in Stroke ...The pooled results demonstrated significant improvements in gait function (SMD = 0.51), gait speed (SMD = 0.47), balance (MD = 4.58), and ...
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 ...
Therapeutic Effects of Robotic-Exoskeleton-Assisted Gait ...Robotic-exoskeleton-assisted gait rehabilitation resulted in better lower limb strength, walking speed, and quality of life in hemiparetic ...
Interim results of exoskeletal wearable robot for gait ...The use of robot-assisted walking devices has been shown to result in a reduction in lower limb muscle activity during ambulation in stroke.
Robotic exoskeleton-assisted walking rehabilitation for ...The effectiveness of RE in stroke patients primarily pertains to the correction of abnormal gait patterns and the enhancement of walking ability. Additional ...
Powered robotic exoskeletons in post-stroke rehabilitation of gaitTwo of the four controlled trials showed no greater improvement in any walking outcomes compared to a control group in chronic stroke. In ...
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