Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01498991
Status:
TERMINATED
Last Update Posted:
2019-05-24
First Post:
2011-12-08
Brief Title:
Spinal Cord Injury Leg Rehabilitation
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Rehabilitation of the Lower Extremity With AMES Following Incomplete Spinal Cord Injury SCI
Status:
TERMINATED
Status Verified Date:
2019-05
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:
AMES
Brief Summary:
The purpose of this study is to determine if individuals with incomplete spinal cord injury SCI who remain unable to walk normally 1 year after their SCIs are able to sense and move the affected legs better after 10-13 weeks of treatment with a new robotic therapy device
The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete SCI will result in improved strength sensation in the legs and improved functional gait in the treated limbs
The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete SCI will result in improved strength sensation in the legs and improved functional gait in the treated limbs
Detailed Description:
Traumatic spinal cord injury SCI affects over 200000 people in the USA with several thousand new injuries each year Most recovery following SCI occurs in the six months following surgery Further recovery after 12 months is unusual
In this study 10 subjects more than 1 year post injury will be enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device The aim of this Phase III study is to investigate the use of assisted movement and enhanced sensation AMES technology in the rehabilitation of the legs of participants with incomplete SCI
In this study 10 subjects more than 1 year post injury will be enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device The aim of this Phase III study is to investigate the use of assisted movement and enhanced sensation AMES technology in the rehabilitation of the legs of participants with incomplete SCI
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS061304-22 | NIH | None | httpsreporternihgovquickSearchR01NS061304-22 |