Soft Robotic Exosuit

Soft Exosuit for Stroke

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
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upbaseline (pre-training evaluation)
Awards & highlights
No Placebo-Only Group

Study 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.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You had a stroke at least 6 months ago.
You have trouble walking properly and it can be seen by others.
You walk very slowly, at a speed of 1 meter per second or less.
You are able to bend your ankle upwards so that your foot forms a right angle with your leg when your knee is straight.
Your normal heart rate when you're not active is between 40 and 100 beats per minute.


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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a site

Who is running the clinical trial?

Spaulding Rehabilitation HospitalOTHER
128 Previous Clinical Trials
10,660 Total Patients Enrolled
25 Trials studying Stroke
1,081 Patients Enrolled for Stroke
Harvard UniversityOTHER
220 Previous Clinical Trials
402,108 Total Patients Enrolled
3 Trials studying Stroke
85 Patients Enrolled for Stroke
Boston University Charles River CampusLead Sponsor
105 Previous Clinical Trials
11,601 Total Patients Enrolled
1 Trials studying Stroke
11 Patients Enrolled for Stroke
Louis N Awad, PhD, PTPrincipal Investigator
Boston University

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, 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, 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
~10 spots leftby Oct 2024