Behavioral Interaction Conditions for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stroke+1 MoreBehavioral Interaction Conditions - Behavioral
Eligibility
18 - 80
All Sexes
What conditions do you have?
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Study Summary

This trial is looking at how humans physically interact with each other and how that might help develop robot controllers that can exhibit human-like behavior.

Eligible Conditions
  • Stroke
  • Spinal Cord Injury

Treatment Effectiveness

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: Change of score at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.

Month 5
Change in step length.
Change in stride length.
Month 5
Change in cadence.
Month 5
Change in Modified Ashworth Scale.
Change in functional gait assessment (FGA)
Month 5
Change in stance time.
Month 5
Change in strength via dynamometer testing.
Month 5
Change in stride variability.
Month 5
Change in 10 meter walking test.
Change in 6 minute walking test.
Month 5
Change in motor output from surface EMG of lower limb muscles
Month 5
Change in BERG balance scale (BBS)
Week 12
Change in lower limb motor control.

Trial Safety

Trial Design

4 Treatment Groups

Clinical Populations Bilateral Lower Limb Exoskeleton (H3/X2)
1 of 4
Healthy Participants Ankle Robot (M1)
1 of 4
Healthy Participants Bilateral Lower Limb Exoskeleton (H3/X2)
1 of 4
Clinical Populations Ankle Robot (M1)
1 of 4

Experimental Treatment

544 Total Participants · 4 Treatment Groups

Primary Treatment: Behavioral Interaction Conditions · No Placebo Group · N/A

Clinical Populations Bilateral Lower Limb Exoskeleton (H3/X2)Experimental Group · 4 Interventions: Behavioral Interaction Conditions, Haptic Impedance Level, Skill Level of Partner, Robot Controller Showcase · Intervention Types: Behavioral, Device, Behavioral, Device
Healthy Participants Ankle Robot (M1)Experimental Group · 3 Interventions: Behavioral Interaction Conditions, Haptic Impedance Level, Skill Level of Partner · Intervention Types: Behavioral, Device, Behavioral
Healthy Participants Bilateral Lower Limb Exoskeleton (H3/X2)Experimental Group · 3 Interventions: Behavioral Interaction Conditions, Haptic Impedance Level, Skill Level of Partner · Intervention Types: Behavioral, Device, Behavioral
Clinical Populations Ankle Robot (M1)Experimental Group · 4 Interventions: Behavioral Interaction Conditions, Haptic Impedance Level, Skill Level of Partner, Robot Controller Showcase · Intervention Types: Behavioral, Device, Behavioral, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change of score at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.

Who is running the clinical trial?

U.S. National Science FoundationFED
30 Previous Clinical Trials
8,281 Total Patients Enrolled
2 Trials studying Stroke
12 Patients Enrolled for Stroke
Shirley Ryan AbilityLabLead Sponsor
173 Previous Clinical Trials
13,158 Total Patients Enrolled
65 Trials studying Stroke
5,616 Patients Enrolled for Stroke
Jose Pons, Ph.DPrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
1 Previous Clinical Trials
100 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Absence of pathology that could cause abnormal movements of extremities (e.g.
You are able to understand and speak English.
You are 5 feet 6 inches (1.7 meters) or taller.
You are able to walk >10m independently on level ground, allowed to use assistive devices or bracing as needed.