Viewing Study NCT06399471



Ignite Creation Date: 2024-05-06 @ 8:28 PM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06399471
Status: COMPLETED
Last Update Posted: 2024-05-03
First Post: 2024-05-01

Brief Title: Personalizing MPK Prescription
Sponsor: Georgia Institute of Technology
Organization: Georgia Institute of Technology

Study Overview

Official Title: Personalizing MPK Prescription for Individuals With Transfemoral Amputation
Status: COMPLETED
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: In current clinical prosthetic practice there is no evidence based method for selecting a microprocessor knee MPK joint for a patient with an above the knee amputation Of individuals with amputation in veteran and service member populations approximately 35 present with an above the knee amputation It is well understood in clinical practice that MPKs provide numerous benefits to patients with amputations above the knee including improved gait safety comfort confidence reduced falls balance patient satisfaction and reduced energy expenditure greater ease in negotiating varying terrains improvements in multi-tasking and cost effectiveness Studies that have investigated commercially available MPKs tend to lump all of them together within a single group rather than teasing out individual differences between each knee Therefore clinicians are left to rely on their own intuition and past experiences with an MPK when selecting for a patient with an above the knee amputation rather than making their decision based on evidence collected from the specific patient This may mean that some individuals with an above the knee amputation may not be receiving the best component for them which may delay or inhibit their rehabilitation potential following their amputation
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None