Ignite Creation Date:
2024-05-06 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03530592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2018-05-21
First Post:
2018-04-10
Brief Title:
Seated Ankle Robot for Foot Drop in Aging and Disabled Populations A Demonstration Project
Sponsor:
Baltimore VA Medical Center
Organization:
Baltimore VA Medical Center
Study Overview
Official Title:
Seated Ankle Robot for Foot Drop in Aging and Disabled Populations A Demonstration Project
Status:
NOT_YET_RECRUITING
Status Verified Date:
2018-05
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:
None
Brief Summary:
The purpose of this research study is to test the utility of an ankle robot in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury
Detailed Description:
Many individuals with central nervous system CNS injuries eg a stroke or peripheral nervous system PNS injuries eg peroneal nerve injury neuropathy radiculopathy andor musculoskeletal injury that affect their ankle movement have residual impairments that affect their walking and balance These impairments include the disability foot drop which increases the risk for falling
This study will focus on PNS injuries that cause foot drop
Current therapy to address foot drop is limited primarily to the use of ankle foot orthoses braces that help keep the foot from hitting the ground to prevent falling Also some individuals with foot drop use functional electrical stimulation to the leg nerve to lift the foot Regardless none of these or other existing methods to address foot drop cures or even improves significantly the underlying neurological deficit behind this disability Braces improve walking safety only while they are worn and functional electrical stimulation does not work when it is turned off or when the nerve has been severely damaged Thus the increased fall risk due to foot drop is generally considered life-long and incurable
The investigators have developed a shoe-interfaced ankle robot with an adaptive control system to assist an individual with ankle movement only as needed Data from the investigators previous studies on foot drop due to stroke show great promise for this ankle robot as a new rehabilitation tool for invididuals with foot drop The investigators would like to utilize our findings from these stroke studies in learning how they can be used for PNS-related foot drop
This study will focus on PNS injuries that cause foot drop
Current therapy to address foot drop is limited primarily to the use of ankle foot orthoses braces that help keep the foot from hitting the ground to prevent falling Also some individuals with foot drop use functional electrical stimulation to the leg nerve to lift the foot Regardless none of these or other existing methods to address foot drop cures or even improves significantly the underlying neurological deficit behind this disability Braces improve walking safety only while they are worn and functional electrical stimulation does not work when it is turned off or when the nerve has been severely damaged Thus the increased fall risk due to foot drop is generally considered life-long and incurable
The investigators have developed a shoe-interfaced ankle robot with an adaptive control system to assist an individual with ankle movement only as needed Data from the investigators previous studies on foot drop due to stroke show great promise for this ankle robot as a new rehabilitation tool for invididuals with foot drop The investigators would like to utilize our findings from these stroke studies in learning how they can be used for PNS-related foot drop
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None