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Soft Robotic Exosuit

Soft Exosuit for Stroke (REAL-m Trial)

N/A

Recruiting

Led By Louis N Awad, PhD, PT

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stroke event occurred at least 6 months ago

Observable gait deficits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-training evaluation)

Awards & highlights

REAL-m Trial Summary

This trial will study the effects of a new exosuit technology on stroke patients' ability to walk. The exosuit helps restore lost function and is worn during high intensity gait training. Researchers hope that this study will help inform future trials on the best candidates and outcomes for this new technology.

REAL-m Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You had a stroke at least 6 months ago.

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You have trouble walking properly and it can be seen by others.

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You walk very slowly, at a speed of 1 meter per second or less.

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You are able to bend your ankle upwards so that your foot forms a right angle with your leg when your knee is straight.

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Your normal heart rate when you're not active is between 40 and 100 beats per minute.

REAL-m Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ retention evaluation (up to 4 weeks post-washout)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~retention evaluation (up to 4 weeks post-washout)

This trial's timeline: 3 weeks for screening, Varies for treatment, and retention evaluation (up to 4 weeks post-washout) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

10-Meter Walk Test (10MWT)

6-Minute Walk Test (6MWT)

Forward propulsion

Secondary outcome measures

Dynamic Motor Control Index

Fugl-Meyer Assessment - Lower Extremity Subsection

Muscle Synergies

REAL-m Trial Design

1Treatment groups

Experimental Treatment

Group I: REAL TrainingExperimental Treatment1 Intervention

Robotic Exosuit Augmented Locomotion (REAL) refers to gait training with soft robotic exosuits, performed under a speed-based approach where participants are asked to walk at faster speeds in treadmill and overground environments. Cues and summary feedback emphasizing walking speed and forward propulsion are provided by the physical therapist to facilitate goal-directed walking practice. Training is progressively challenging based on environmental complexity and practice variability. REAL includes 12 training sessions, administered 2-3x/week. Each session includes 30 minutes of total walking time.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalOTHER

133 Previous Clinical Trials

10,998 Total Patients Enrolled

25 Trials studying Stroke

1,072 Patients Enrolled for Stroke

Harvard UniversityOTHER

229 Previous Clinical Trials

474,563 Total Patients Enrolled

3 Trials studying Stroke

69 Patients Enrolled for Stroke

Boston University Charles River CampusLead Sponsor

113 Previous Clinical Trials

12,136 Total Patients Enrolled

2 Trials studying Stroke

55 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must an individual fulfill to be eligible for participation in this clinical trial?

"This clinical trial is seeking around 25 patients with a history of stroke between 18 and 80 years old."

Answered by AI

Does this research extend to people of a more senior age bracket?

"As per the trial's requirements, enrollment is only available to individuals aged 18 and above but no older than 80 years."

Answered by AI

What is the size of the cohort participating in this clinical exploration?

"Affirmative. Examining the data hosted on clinicaltrials.gov, we can see that this medical experiment is actively recruiting volunteers since its introduction on March 14th 2022 and latest update at the end of the month. A total of 25 participants are needed to be accepted from a single centre."

Answered by AI

Are there still vacant slots for participants in this research endeavor?

"As per the information lodged on clinicaltrials.gov, this medical trial is actively enlisting participants with recruitment beginning on March 14th 2022 and last updated on March 30th 2022."

Answered by AI

Recent research and studies

Neurorehabilitation and Neural RepairJournal

Feasibility and Potential Efficacy of High-intensity Stepping Training in Variable Contexts in Subacute and Chronic Stroke

Holleran, Carey L., Don D. Straube, Catherine R. Kinnaird, Abigail L. Leddy, and T. George Hornby. 2014. “Feasibility and Potential Efficacy of High-intensity Stepping Training in Variable Contexts in Subacute and Chronic Stroke”. Neurorehabilitation and Neural Repair. SAGE Publications. doi:10.1177/1545968314521001.

IEEE Open Journal of Engineering in Medicine and BiologyJournal

Walking Faster and Farther with a Soft Robotic Exosuit: Implications for Post-stroke Gait Assistance and Rehabilitation

Awad, Louis N., Pawel Kudzia, Dheepak Arumukhom Revi, Terry D. Ellis, and Conor J. Walsh. 2020. “Walking Faster and Farther with a Soft Robotic Exosuit: Implications for Post-stroke Gait Assistance and Rehabilitation”. IEEE Open Journal of Engineering in Medicine and Biology. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/ojemb.2020.2984429.

Frontiers in NeuroroboticsJournal

Targeting Paretic Propulsion and Walking Speed with a Soft Robotic Exosuit: A Consideration-of-concept Trial

Porciuncula, Franchino, Teresa C. Baker, Dheepak Arumukhom Revi, Jaehyun Bae, Regina Sloutsky, Terry D. Ellis, Conor J. Walsh, and Louis N. Awad. 2021. “Targeting Paretic Propulsion and Walking Speed with a Soft Robotic Exosuit: A Consideration-of-concept Trial”. Frontiers in Neurorobotics. Frontiers Media SA. doi:10.3389/fnbot.2021.689577.

Journal of Rehabilitation MedicineJournal