Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-01 @ 12:18 AM
Study NCT ID:
NCT03222505
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2017-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Walk Assist Device to Improve Community Ambulation
Sponsor:
Shirley Ryan AbilityLab
Organization:
Study Overview
Official Title:
Development of Walk Assist Device to Improve Community Ambulation
Status:
COMPLETED
Status Verified Date:
2019-08
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:
None
Brief Summary:
The goal of this research study was to examine the immediate effects of a prototype wearable robotic stride management assist device (SMA) designed by Honda R\&D® on clinical walking performance, walking energetics, gait kinematics and corticospinal excitability in individuals with stroke.
Detailed Description:
The goal of this research study was to examine the immediate effectiveness of a prototype wearable robotic stride management assist device (SMA) designed by Honda R\&D on clinical walking performance, walking energetics, gait kinematics and corticospinal excitability in individuals with stroke.
The SMA assists walking by providing a flexion and extension torque assist at the hip joint. The subjects in this study are asked to perform two sets of experiments: one set with the device on and one set with the device turned off. The order in which the subjects performed these sets of experiments is selected randomly. Each set of experiments includes over-ground walking speed and endurance tests, a graded treadmill test with metabolic measures, motion capture and force treadmill analysis, and measures of corticospinal drive using transcranial magnetic stimulation (TMS). The primary outcome to be measured is change in self-selected walking speed with the device on, the secondary outcome measures include metabolic, corticospinal and biomechanical analysis.
The SMA assists walking by providing a flexion and extension torque assist at the hip joint. The subjects in this study are asked to perform two sets of experiments: one set with the device on and one set with the device turned off. The order in which the subjects performed these sets of experiments is selected randomly. Each set of experiments includes over-ground walking speed and endurance tests, a graded treadmill test with metabolic measures, motion capture and force treadmill analysis, and measures of corticospinal drive using transcranial magnetic stimulation (TMS). The primary outcome to be measured is change in self-selected walking speed with the device on, the secondary outcome measures include metabolic, corticospinal and biomechanical analysis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: