Viewing Study NCT06636045



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06636045
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-08

Brief Title: Blood Flow Restriction Following ACLR WQuad Autograft
Sponsor: None
Organization: None

Study Overview

Official Title: Effect of Blood Flow Restriction BFR on Rehabilitation Protocols Following Anterior Cruciate Ligament Reconstruction ACLR with Quadricep Autograft
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
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: BFR Quad Delay
Brief Summary: This project is intended to acquire objective measurements of implementing BFR rehabilitation in ACL reconstructions to show any changes upon completion of the BFR protocol The results in this study will hopefully represent valuable data in the support of using autografts for ACL reconstructions in high level athletes wanting a full recovery and return to high level of sport

It has been speculated that use of autografts in ACL reconstructions leads to more quad weakness and muscle atrophy due to tendon harvesting Slone et al 2015 More recently BFR has shown promise in expediting the recovery and rehabilitation process post-surgically By implementing BFR following ACL reconstructions with autografts we hope to mitigate the major deterrent for autograft use and giving patients a more cost-effective approach to surgery Hughes et al 2019
Detailed Description: Specific Aim 1 will identify the overall preservation of muscle and changes in body composition after injury and throughout surgical rehabilitation in athletes undergoing ACL reconstruction It is hypothesized that implementing BFR rehabilitation protocols following ACL reconstruction with autografts will expedite recovery and return to sport and rescue of muscle tissue at the donor site

Specific Aim 2 will monitor muscle strength and activation following ACL reconstruction with performance of standardized assessments at intervals It is hypothesized that BFR implementation will show greater return to strength and enhanced muscle activation during testing

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