Exoskeleton-Assisted Walking for Stroke Rehabilitation

Overseen By Meheroz H Rabadi, MD, MRCPI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Aphasia, Confusion, Medically unstable, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 4 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an electromechanical exoskeleton can help stroke patients improve walking ability during rehabilitation. Participants will receive either standard rehabilitation or standard rehabilitation plus the use of an Indego Exoskeleton. The study aims to determine if the exoskeleton provides better recovery outcomes. It suits individuals who have had a stroke, can stand independently, and are stable enough for daily therapy sessions. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future rehabilitation therapies.

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.

What prior data suggests that the Indego Exoskeleton is safe for stroke rehabilitation?

Research has shown that the Indego Exoskeleton, designed to assist walking, presents some safety concerns. Some studies found that improper fit can lead to discomfort or injuries. Misalignment with the body may cause pain or require the user to expend more energy.

The Indego Exoskeleton has received approval for aiding individuals with certain spinal cord injuries, indicating it meets safety standards for these cases. Although not yet approved specifically for stroke rehabilitation, it has been tested and used in similar contexts.

Regarding benefits, reports suggest users experience improved movement, reduced fatigue, and enhanced mood. Despite known risks, the exoskeleton's use in healthcare settings suggests it is safe and effective for certain conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exoskeleton-assisted walking for stroke rehabilitation because it offers a new way to enhance recovery beyond traditional physical therapy. Unlike standard rehabilitation, which typically involves exercises and manual assistance, the Indego Exoskeleton provides robotic support to help patients walk. This technology not only aids in physical movement but also promotes neuroplasticity, enabling the brain to relearn and improve motor functions more effectively. By integrating advanced robotics, this approach has the potential to speed up recovery and improve mobility outcomes for stroke survivors.

What evidence suggests that the Indego Exoskeleton is effective for stroke rehabilitation?

Research has shown that the Indego Exoskeleton, which participants in this trial may use, might help stroke patients walk better. One review found that using an exoskeleton for walking practice can be effective for individuals who have had a stroke for a long time. Another study found that stroke patients using robotic exoskeletons experienced better knee movement than those who did not use them. However, some studies have shown mixed results, with no major improvement in walking compared to regular therapy. Overall, exoskeletons could be useful in rehabilitation, but their effectiveness can vary. Participants in this trial will be divided into two groups: one receiving standard rehabilitation alone and the other receiving standard rehabilitation plus the use of the Indego Exoskeleton. ^{1 6 7 8 9}

Who Is on the Research Team?

Meheroz Rabadi, MD, MRCPI

Principal Investigator

Affiliate; Oklahoma VA Health Care System

Are You a Good Fit for This Trial?

This trial is for patients who have had a stroke and are stable enough to do daily therapies. They must be able to understand the study (with an MMSE score of at least 21), give written consent, and stand on their own. People with severe communication issues or confusion, those who can't stand alone, or refuse to consent cannot join.

Inclusion Criteria

I have had a stroke confirmed by a doctor and scans.

My heart and lungs are stable enough for daily treatments.

I can stand up by myself.

Exclusion Criteria

Refusal to provide written informed consent

Patients medically unstable

People who are not able to think clearly or understand things well.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily 3-hour conventional therapy plus an hour of either exoskeleton or over-ground gait training 3 times per week for 4 weeks

4 weeks

12 visits (in-person)

Follow-up

Participants are monitored for changes in FIM, depression, and spasticity scores, as well as discharge disposition

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Indego Exoskeleton
• Standard Rehabilitation

Trial Overview The study tests if using an electromechanical exoskeleton (Indego Exoskeleton) during gait training helps improve walking and movement better than standard rehabilitation alone in stroke patients at an in-patient facility.

How Is the Trial Designed?

Group I: Exo-group Experimental Treatment 2 Interventions

Standard rehabilitation plus use of Exoskeleton

Group II: Control-Group Placebo Group 1 Intervention

Standard rehabilitation

Indego Exoskeleton is already approved in European Union, United States for the following indications:

Approved in European Union as Indego Exoskeleton for:

• Spinal cord injuries
• Stroke rehabilitation

Approved in United States as Indego Exoskeleton for:

• Spinal cord injuries
• Stroke rehabilitation

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

The study involving 46 subacute stroke patients demonstrated that overground exoskeleton-assisted gait training (OEAGT) significantly improved clinical and gait outcomes, with many patients regaining the ability to walk after treatment.

Patients reported a positive acceptance of the OEAGT, indicating its potential as an innovative rehabilitation strategy, although further randomized studies with larger samples are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. Goffredo, M., Guanziroli, E., Pournajaf, S., et al.[2020]

Lower limb exoskeletons like ReWalk™, Mina, and Indego® have shown effectiveness for walking in controlled laboratory settings for individuals with paraplegia, but their long-term applicability and effectiveness in real-world community settings remain unproven.

The ReWalk™ exoskeleton demonstrated the best walking performance, achieving a maximum speed of 0.51 m/s after 45 sessions, but overall evidence supporting the use of these devices is low, indicating a need for further research on their long-term benefits compared to traditional mobility aids like wheelchairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exoskeletons' design and usefulness evidence according to a systematic review of lower limb exoskeletons used for functional mobility by people with spinal cord injury. Lajeunesse, V., Vincent, C., Routhier, F., et al.[2018]

Robotic-assisted gait training (RAGT) using the EksoNR exoskeleton significantly improved gait and functional status in 19 stroke patients over a 4-week rehabilitation program, with notable enhancements in walking ability and mobility.

The study showed statistically significant improvements in various functional categories, including a substantial increase in the number of steps taken and walking time, indicating that RAGT is both effective and well-tolerated for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Rehabilitation Outcomes of Robotic-Assisted Gait Training with EksoNR Lower Extremity Exoskeleton in 19 Stroke Patients. Wiśniowska-Szurlej, A., Wołoszyn, N., Brożonowicz, J., et al.[2023]

Exoskeleton-assisted Body Weight Supported Treadmill Training (BWSTT) shows promise in improving gait function in patients with chronic stroke, with 10 out of 11 studies indicating positive outcomes for walking ability among 309 participants.

While exoskeleton-assisted BWSTT appears effective, it may primarily serve as an assistive tool rather than providing significant advantages over traditional therapist-assisted training, highlighting the need for further research to clarify its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exoskeleton-assisted Body Weight-Supported Treadmill Training on gait function for patients with chronic stroke: a scoping review. Yamamoto, R., Sasaki, S., Kuwahara, W., et al.[2023]

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]

The Indego powered exoskeleton was found to be safe for use in 32 nonambulatory individuals with spinal cord injuries, with limited device-related adverse events and no interruptions in training over an 8-week period.

Participants showed significant improvements in walking speed and endurance in both indoor and outdoor conditions, as well as increased independence in donning and doffing the exoskeleton after the training program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury. Tefertiller, C., Hays, K., Jones, J., et al.[2019]

Intensity modulated robotic exoskeleton gait training significantly improved walking speed and functional mobility in stroke survivors over a 10-week period, with participants training at 75-85% of their maximum heart rates during 30 sessions.

These preliminary results suggest that using robotic exoskeletons for gait training can enhance motor recovery and functional ambulation in post-stroke rehabilitation, although further research is needed to fully understand the benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity Modulated Exoskeleton Gait Training Post Stroke. Nolan, KJ., Ames, GR., Dandola, CM., et al.[2023]

In a study of 44 patients aged 55-85 who had ischemic strokes, using the Ekso GT exoskeleton for rehabilitation showed improvements in balance and functional status compared to traditional rehabilitation methods over 4 weeks.

While both rehabilitation methods led to functional improvements, the exoskeleton group demonstrated greater benefits in multiple categories, suggesting it may be a more effective tool for enhancing recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exoskeleton Gait Training on Balance, Load Distribution, and Functional Status in Stroke: A Randomized Controlled Trial. Rojek, A., Mika, A., Oleksy, Ł., et al.[2020]

Integrating the Ekso Gait Training device into inpatient rehabilitation for patients with stroke or spinal cord injury is feasible, although it faced initial challenges that required administrative support and clinician persistence over several months.

Patients using the Ekso reported improved mobility and tolerated the sessions well, with no complications or adverse incidents, indicating a positive experience with the robotic exoskeleton.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. Swank, C., Sikka, S., Driver, S., et al.[2021]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9768983/

Effect of exoskeleton-assisted Body Weight-Supported ... This review suggests that exoskeleton-assisted BWSTT for patients with chronic stroke may be effective in improving walking function.

2. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-016-0162-5

Powered robotic exoskeletons in post-stroke rehabilitation of gait Two of the four controlled trials showed no greater improvement in any walking outcomes compared to a control group in chronic stroke. In ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7852187/

Systematic review on wearable lower-limb exoskeletons for ... The results of the literature survey reveal that wearable exoskeletons have potential for a number of applications including early ...

4. 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.

5. withpower.com withpower.com/trial/phase-paresis-2025-c0f84

Robotic Exoskeletons for Stroke Recovery (RERC Trial) In a study of 38 post-stroke patients, those who received robotic-exoskeleton-assisted rehabilitation showed significantly greater improvements in knee flexion ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03980457

Effects of Exoskeleton-Assisted Gait Training on Functional ... The intervention is Indego® exoskeleton. The primary outcome measures were: changes in the FIM, depression and spasticity scores. The secondary outcome measure ...

7. blueshieldca.com blueshieldca.com/content/dam/bsca/en/provider/docs/2023/May/PRV_PwrdExoskel_AmbPts_LowLimbDisablilities.pdf

1.03.04 Powered Exoskeleton for Ambulation in Patients ... Indego is “intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5562031/

Clinician-Focused Overview of Bionic Exoskeleton Use After ... The powered exoskeleton from Ekso Bionics is the only overground-walking exoskeleton with FDA approval for stroke rehabilitation, although studies examining ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875024001906

Exoskeleton-Assisted Rehabilitation and Neuroplasticity in ... The results revealed substantial improvements in lower extremity motor function, along with positive changes in fatigue levels, quality of life, and mood trends ...