Robotic Exoskeleton for Stroke

Overseen By Katelyn Aragon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Severe osteoporosis, Serious cardiac conditions, Uncontrolled hypertension, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop and refine the WIM Robotic Exoskeleton to help stroke survivors improve mobility. The wearable robot assists with walking and enhances rehabilitation efforts. Individuals at least six months post-stroke or with conditions like Parkinson's or multiple sclerosis, who can walk at least 10 meters with minimal assistance, may be suitable candidates. Participants should not have severe heart conditions or severe osteoporosis and must safely fit into the exosuit during an in-person fitting. Healthy individuals with no known impairments are also welcome to participate. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research and potentially enhance their mobility with innovative technology.

Do I need to stop my current medications to join 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 exoskeleton is safe for individuals who have experienced a stroke?

Research has shown that powered robotic exoskeletons, such as the WIM Robotic Exoskeleton, have been used safely in stroke patients. Early studies indicate that users generally find these devices easy to handle, with few reports of serious side effects. One study examined a similar robotic hip exoskeleton and found it safe and effective for use outside a hospital. This suggests that the WIM Robotic Exoskeleton might also be safe for use. However, as this technology is still under study, participating in a trial is important to better understand its safety and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WIM Robotic Exoskeleton because it offers a new approach to rehabilitating stroke patients. Unlike traditional therapies that rely on manual exercises and physical therapy, this advanced exoskeleton uses robotics to provide precise, consistent support and movement assistance. This technology can potentially accelerate recovery by enhancing motor learning and promoting neuroplasticity, which are crucial in regaining mobility after a stroke. By integrating robotics, this treatment aims to offer more efficient, personalized rehabilitation, potentially leading to better outcomes for stroke survivors.

What evidence suggests that the WIM Robotic Exoskeleton is effective for stroke recovery?

Research has shown that robotic exoskeletons can help stroke survivors relearn walking. Some studies suggest these devices ease walking by reducing the effort required from leg muscles. While not all studies agree on the extent of the benefits, some have found significant improvements in leg function for stroke survivors. In this trial, participants will use the WIM Robotic Exoskeleton, which specifically aids hip movement and may enhance overall mobility. Although more research is needed, these early results are promising for stroke recovery. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-89 who have had a stroke, Parkinson's, multiple sclerosis, or are healthy older adults over 65 with no neurological diagnoses. Participants must be able to walk at least 10 meters with minimal assistance and fit into the WIM exosuit. Exclusions include recent major surgery, serious cardiac conditions, uncontrolled hypertension, severe spasticity in hip muscles post-stroke or MS, skin issues affecting exosuit use, pregnancy, severe osteoporosis or certain pre-existing conditions.

Inclusion Criteria

For the Optimization Aim of the study, healthy individuals with no known impairments are also eligible

For stroke, Parkinson's, multiple sclerosis, or older adult participants, must have adequate cognitive function (MMSE score >17)

I am over 6 months post-stroke, have Parkinson's, MS, or am over 65 with no neurological conditions.

Exclusion Criteria

I had major joint surgery less than 3 months ago.

It has been less than 6 months since my heart surgery.

I do not have serious heart conditions or recent heart surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Optimization

Participants engage in a single session to test and optimize the soft hip wearable robot

Single session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the optimization session

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• WIM Robotic Exoskeleton

Trial Overview The study tests a soft hip wearable robot (WIM Robotic Exoskeleton) designed to enhance walking activity in people who've had a stroke. The aim is to develop and optimize this technology for better mobility support in affected individuals as well as healthy participants.

How Is the Trial Designed?

Group I: Healthy Population Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9980569/

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 ...

2. nature.com nature.com/articles/s41598-025-96084-6

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.

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1453781/full

Effect of robotic exoskeleton training on lower limb function ... This review aims to analyze LRET' s efficacy for stroke patients, based on ICF, and explore the impact of intervention intensities, devices, and stroke phases.

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01662-4

Upper limb robotic rehabilitation following stroke: a systematic ... The results suggest that robotic rehabilitation does not result in clinically meaningful improvement in either upper limb capacity or ADL performance.

5. medicalsciencepulse.com medicalsciencepulse.com/article/549895/en

Clinical outcomes in post-stroke rehabilitation using upper ... Conclusions: Our analysis indicates that upper limb rehabilitation using robotic exoskeletons significantly improves the movement of proximal ...

6. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07061691

WIM Robotic Exoskeleton in Stroke - Clinical Trials Registry This study is to develop, test, and optimize a soft hip wearable robot for individuals who have experience a stroke.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6988257/

Exoskeleton for post-stroke recovery of ambulation (ExStRA) Early research has demonstrated safe use of powered robotic exoskeletons for individuals with stroke, but few clinical trials have been ...

8. frontiersin.org frontiersin.org/journals/stroke/articles/10.3389/fstro.2024.1379083/full

Exoskeleton-assisted training to enhance lower limb motor ... This pilot trial shows the feasibility of investigating a wearable exoskeleton as an adjunct therapy in subacute stroke.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03727919

Exoskeleton-assisted Training to Accelerate Walking ... In two closely inter-related phases, we aim to examine the biomechanical changes related to walking recovery in general (Phase I) and the specific effects of ...

10. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01421-x

Safety & efficacy of a robotic hip exoskeleton on outpatient ... The objective of this study was to analyze the safety and efficacy of using a robotic hip exoskeleton designed by Samsung Electronics Co., Ltd., ...