Exoskeleton-Assisted Walking for Stroke Rehabilitation

Recruiting in Palo Alto (17 mi)

Overseen by Meheroz Rabadi, MD, MRCPI

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Oklahoma

Disqualifiers: Aphasia, Confusion, Medically unstable, others

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.

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 data supports the effectiveness of the treatment Indego Exoskeleton for stroke rehabilitation?

Research shows that using robotic exoskeletons like the Ekso GT and EksoNR can improve walking ability and balance in stroke patients. These devices help patients practice walking in a controlled way, which can lead to better mobility and functional recovery compared to traditional therapy, especially in the early stages after a stroke. ^{1 2 3 4 5}

Is exoskeleton-assisted walking safe for stroke rehabilitation?

Research shows that exoskeletons like Indego and Ekso are generally safe for use in rehabilitation, with limited adverse events reported in studies involving people with spinal cord injuries and stroke. Patients tolerated sessions well, without complications, and felt secure using the devices. ^{1 2 6 7 8}

How is the Indego Exoskeleton treatment different from other stroke rehabilitation treatments?

The Indego Exoskeleton treatment is unique because it uses a wearable robotic device to assist with walking, allowing for intensive, repetitive gait training that can enhance motor recovery in stroke patients. This approach is particularly beneficial for sub-acute stroke patients and offers a novel way to engage patients actively in their rehabilitation, potentially leading to better outcomes compared to traditional therapies. ^{2 4 5 9 10}

Research Team

Meheroz Rabadi, MD, MRCPI

Principal Investigator

Affiliate; Oklahoma VA Health Care System

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Indego Exoskeleton (Exoskeleton)
• Standard Rehabilitation (Behavioural Intervention)

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.

Participant Groups

Group I: Exo-group Experimental Treatment 2 Interventions

Standard rehabilitation plus use of Exoskeleton

Group II: Control-Group Placebo Group 1 Intervention

Standard rehabilitation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Oklahoma City VA Health Care System Oklahoma City, OK

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Patients Recruited

95,900+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Intensity Modulated Exoskeleton Gait Training Post Stroke. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Enhanced Rehabilitation Outcomes of Robotic-Assisted Gait Training with EksoNR Lower Extremity Exoskeleton in 19 Stroke Patients. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. [2020]

8. England 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. [2018]

9. Italy pubmed.ncbi.nlm.nih.gov

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. [2020]

10. England 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. [2023]