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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
Be older than 18 years old
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 Timeline

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.

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalOTHER
135 Previous Clinical Trials
11,015 Total Patients Enrolled
25 Trials studying Stroke
984 Patients Enrolled for Stroke
Harvard UniversityOTHER
230 Previous Clinical Trials
474,600 Total Patients Enrolled
3 Trials studying Stroke
69 Patients Enrolled for Stroke
Boston University Charles River CampusLead Sponsor
114 Previous Clinical Trials
12,265 Total Patients Enrolled
2 Trials studying Stroke
55 Patients Enrolled for Stroke
~8 spots leftby May 2025
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