Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406491
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-06
Brief Title:
Passive Microprocessor-controlled Knees vs Active Microprocessor-controlled Knees After Transfemoral Amputation
Sponsor:
Median
Organization:
Median
Study Overview
Official Title:
Application Observation of Passive Microprocessor-controlled Knees vs Active Microprocessor-controlled Knees After Transfemoral Amputation
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This study investigates prosthetic users report of passive microprocessor-controlled knees pMPK vs active microprocessor-controlled knees aMPK Outcome measurements are assessed at baseline with the pMPK and after 4 weeks of continuous use of aMPK Measurements consists of functional outcomes as well as patient-reported outcomes
Detailed Description:
The Intuy Knee an active electronic microprocessor-controlled prosthesis aims to improve symmetry in joints torque and muscle activation compared to passive prostheses Furthermore it provides benefits of active prostheses in terms of weight distribution stair climbing ease and reduced oxygen consumption However theres a lack of research on subjective evaluation by participants Thus the study aims to compare the Intuy Knee with passive prostheses regarding functional outcomes and patient-reported outcomes PROMs
The target group includes individuals with transfemoral amputation or knee disarticulation aged 18 and above with anticipated moderate to high mobility levels and currently using an electronic prosthetic knee The study plans to enroll participants nearing the end of their prosthetic cycle allowing for comparison between different prosthetic options
Key objectives include comparing walking distance stair climbing and hill ascent between passive and active prostheses as well as evaluating mobility daily functionality quality of life and fear of falling
The study design is prospective with a pre-post design aiming for an intra-individual comparison between active and passive prostheses It outlines inclusion and exclusion criteria study procedures and discontinuation criteria for both individual and overall study termination
The target group includes individuals with transfemoral amputation or knee disarticulation aged 18 and above with anticipated moderate to high mobility levels and currently using an electronic prosthetic knee The study plans to enroll participants nearing the end of their prosthetic cycle allowing for comparison between different prosthetic options
Key objectives include comparing walking distance stair climbing and hill ascent between passive and active prostheses as well as evaluating mobility daily functionality quality of life and fear of falling
The study design is prospective with a pre-post design aiming for an intra-individual comparison between active and passive prostheses It outlines inclusion and exclusion criteria study procedures and discontinuation criteria for both individual and overall study termination
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