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Sensory Augmentation for Stroke (SAM Trial)

Phase < 1
Waitlist Available
Led By Jesse C. Dean, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to walk on a treadmill without a cane or walker
Gait speed of at least 0.2 m/s
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-weeks
Awards & highlights

SAM Trial Summary

This trial found that when chronic stroke survivors were given sensory feedback while walking, they improved their foot placement accuracy and balance.

SAM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You can walk at a speed of at least 0.2 meters per second.
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You had a stroke within the last 6 months.

SAM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in mechanics-dependent adjustment of paretic foot placement
Intervention Feasibility (adherence)
Intervention Feasibility (drop-out)
+1 more
Secondary outcome measures
Change in Activity-specific Balance Confidence score
Change in Functional Gait Assessment score
Change in fear of falling
+2 more

SAM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sensory augmentationExperimental Treatment1 Intervention
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Group II: Random vibrationActive Control1 Intervention
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sensory Augmentation
2022
Completed Early Phase 1
~60

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,552 Total Patients Enrolled
82 Trials studying Stroke
6,575 Patients Enrolled for Stroke
Jesse C. Dean, PhDPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
2 Previous Clinical Trials
90 Total Patients Enrolled
2 Trials studying Stroke
90 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 is the overarching goal of this scientific endeavor?

"The primary assessment of this 4-week trial will be to gauge patient adherence. Secondary objectives include tracking changes in overground walking speed, total walking time across training sessions and activity specific balance confidence score."

Answered by AI
~15 spots leftby Mar 2025