Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522646
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System SPCM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System SPCM
Status:
COMPLETED
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:
SPCM
Brief Summary:
The main aim of this study is to compare the adaptation capabilities of the microprocessor-controlled knee-ankle prosthesis system with the comparator covered by the French LPPR known as the usual prosthesis
The main hypothesis being that wearing the SPCM increases the time spent flat-footed in the various walking situations of everyday life bringing it closer to that of asymptomatic people
This is a prospective multicenter randomized cross-over study The participants are transfemoral amputees who have been fitted with a microprocessor-controlled prosthetic knee for more than 3 months
The main hypothesis being that wearing the SPCM increases the time spent flat-footed in the various walking situations of everyday life bringing it closer to that of asymptomatic people
This is a prospective multicenter randomized cross-over study The participants are transfemoral amputees who have been fitted with a microprocessor-controlled prosthetic knee for more than 3 months
Detailed Description:
None
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