NCT04309305

Robotic Exoskeleton Assisted Gait Post Stroke

Functional and Neurophysiological Effects of a Progressive Robot Assisted Gait Intervention Early Post Stroke

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The current investigation takes advantage of both a progressive and adaptive assist-as-needed massed practice and time-sensitive neuroplasticity through exoskeleton assisted walking in order to induce greater recovery-oriented CNS plasticity and consequent gains in more independent walking.

Detailed description

The purpose of this research study is to assess whether using a wearable device, called the robotic exoskeleton (RE), can be helpful in improving recovery of walking in adults who have recently had a stroke. The study will compare the walking abilities of people who went through standard of care treatment after a stroke to those who used the robotic exoskeleton as part of their rehabilitation. This study will also look at the effects walking in the RE has on brain activity. The name of the robotic exoskeleton that is being used in this study is the EksoTM.

Conditions

• CVA
• Gait, Hemiplegic

Interventions

Type	Name	Description
DEVICE	EksoGT™, Ekso Bionics, Berkley, CA, USA	The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking.
OTHER	Standard of Care	Standard gait therapy provided by licensed physical therapists post stroke.
OTHER	No Intervention	Testing Only

Timeline

• Start date: 2020-01-30
• Primary completion: 2026-05-01
• Completion: 2026-09-01
• First posted: 2020-03-16
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study