Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503354
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
Gait Metric Validation of the Cionic Neural Sleeve
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation of Gait Metrics From Cionic Neural Sleeve
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the validity of the Neural Sleeve gait metrics compared to gait parameters assessed with a Protokinetics Zeno pressure sensitive walkway The spatiotemporal gait parameters obtained from the Zeno walkway have been rigorously validated and will represent the gold standard ground truth measurements in the proposed protocol Confirming the validity of the Neural Sleeve metrics offers benefit to individuals who utilize the device by providing confidence that calculated gait reports are accurate and can be used to inform usage of the device and associated gait changes over time Findings of innaccuracy would still offer benefit in the form of knowing that the Neural Sleeve metrics need to be used with caution andor updated to provide correct outcomes to users
Detailed Description:
The study aims to validate the gait metrics of the Neural Sleeve in healthy adult volunteers All participants will wear a Neural Sleeve on their dominant leg The Zeno pressure gait mat will be laid flat on the ground and used for all walking conditions Overall participants will perform three 5 minute walking bouts without electrical stimulation Two walking conditions will be performed while wearing the Neural Sleeve however no electrical stimulation will be utilized The movement sensors on the Neural Sleeve will collect motion data that permits the comparison of gait metrics from the Sleeve to those measured by the gait mat During the walking trials participants will be told that they can take a break if needed Condition order will be randomized and participants will be offered 5 minutes of rest between consecutive trials Validity of gait metrics of the Neural Sleeve will be compared against the Zeno walkway
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