Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05740553
Status:
TERMINATED
Last Update Posted:
2023-03-06
First Post:
2023-02-13
Brief Title:
Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury
Sponsor:
The University of Texas at Dallas
Organization:
The University of Texas at Dallas
Study Overview
Official Title:
Using the ReTrieve Automated Stereognosis System to Treat Loss of Tactile Function After Brain Injury
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate participant recruitment potentially due to COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReTrieve
Brief Summary:
Researchers aim to determine whether the ReTrieve system for tactile training can improve tactile function sense of touch in the hand after brain injury when used at home for 6 weeks
Detailed Description:
All participants who have been found eligible for this study and given informed consent will be randomized into two groups- either participants will begin ReTrieve training immediately following an initial assessment or wait 8 weeks before beginning training
During the study participants will have a ReTrieve tactile training system delivered home for use over 6 weeks Investigators will take three days to teach participants how to use the system Each week for the remainder of the 6 weeks participants will use this system for 4 days per week on their own and for 1 day supervised During each supervised day participants will complete approximately 1 hour of training while supervised over video chat with researchers
Participants tactile function will be assessed at three separate time points once within one week before beginning training once within one week after completing training as well as once either 8 weeks before or 8 weeks after the training This assessment has a required survey component as well as an optional in-person clinical assessment component
During the study participants will have a ReTrieve tactile training system delivered home for use over 6 weeks Investigators will take three days to teach participants how to use the system Each week for the remainder of the 6 weeks participants will use this system for 4 days per week on their own and for 1 day supervised During each supervised day participants will complete approximately 1 hour of training while supervised over video chat with researchers
Participants tactile function will be assessed at three separate time points once within one week before beginning training once within one week after completing training as well as once either 8 weeks before or 8 weeks after the training This assessment has a required survey component as well as an optional in-person clinical assessment component
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None