Viewing Study NCT04309305


Ignite Creation Date: 2025-12-25 @ 3:25 AM
Ignite Modification Date: 2025-12-26 @ 2:05 AM
Study NCT ID: NCT04309305
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2025-04-06
First Post: 2020-02-10
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Robotic Exoskeleton Assisted Gait Post Stroke
Sponsor: Kessler Foundation
Organization:

Study Overview

Official Title: Functional and Neurophysiological Effects of a Progressive Robot Assisted Gait Intervention Early Post Stroke
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2025-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: RE-Assist
Brief 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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: