Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT04709367
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2021-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of Residual Limb Volume Changes in Transfemoral Amputees
Sponsor:
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Organization:
Study Overview
Official Title:
Characterization of Residual Limb Volume Changes in Transfemoral Amputees: Descriptive Prospective Longitudinal Observational Study.
Status:
COMPLETED
Status Verified Date:
2021-01
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:
This study quantifies residual limb volume fluctuations affecting transfemoral amputees due to the prosthesis doffing, physical activity, and testing time.
Detailed Description:
The first test session aims at measuring residual limb volume at 7 time-points, with 10 minute intervals, after prosthesis doffing. This allows for evaluating the time required for volume stabilization after prosthesis removal, for each amputee. In subsequent sessions, 16 residual limb scans in a day for each amputee are captured to evaluate volume changes due to prosthesis removal and physical activity, in two times per day (one in the morning, one in the afternoon). These measurements are repeated in three different days, a week apart from each other, for a total of 48 scans for each amputee.
Study Oversight
Has Oversight DMC:
False
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?: