Soft Exosuit for Stroke (REAL-m Trial)

N/A

Waitlist Available

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

No Placebo-Only Group

Summary

This trial tests soft robotic exosuits to help stroke patients walk better by supporting their ankles. The goal is to see if these exosuits can improve walking ability through intense training. Researchers will measure how well patients walk and move over time to understand their effectiveness. Soft robotic exosuits have been shown to facilitate immediate increases in walking speeds and improve walking performance in people with post-stroke hemiparesis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

10-Meter Walk Test (10MWT)

6-Minute Walk Test (6MWT)

Forward propulsion

Secondary study objectives

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Soft Exosuit

2022

N/A

~30

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