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Soft Robotic Exosuit
REAL training for Stroke (REAL Trial)
N/A
Waitlist Available
Research Sponsored by Lou Awad, PT, DPT, PhD
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 Trial Summary
This study is evaluating whether an exosuit may help improve walking ability in individuals with stroke.
REAL 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)
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)
Secondary outcome measures
Dynamic Motor Control Index
Forward propulsion
Muscle Synergies
REAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
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.
Group II: Control trainingActive Control1 Intervention
Control training refers to similarly structured gait training as with REAL, with the only exception of using soft robotic exosuits. Control training is 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 physical therapist to facilitate goal-directed walking practice. Training is progressively challenging based on environmental complexity and practice variability. Control training 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
2021
N/A
~20
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Who is running the clinical trial?
Lou Awad, PT, DPT, PhDLead Sponsor
Harvard UniversityOTHER
229 Previous Clinical Trials
474,475 Total Patients Enrolled
3 Trials studying Stroke
64 Patients Enrolled for Stroke
Spaulding Rehabilitation HospitalOTHER
135 Previous Clinical Trials
11,025 Total Patients Enrolled
25 Trials studying Stroke
979 Patients Enrolled for Stroke
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