Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
Study NCT ID:
NCT06762392
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2024-12-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Blood Flow Restriction in Postoperative Rehabilitation for Anterior Cruciate Ligament Injuries. A Pilot Study.
Sponsor:
University of Valencia
Organization:
Study Overview
Official Title:
Effectiveness of Blood Flow Restriction in Postoperative Rehabilitation for Anterior Cruciate Ligament Injuries. A Pilot Study.
Status:
RECRUITING
Status Verified Date:
2025-01
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:
The goal of this clinical trial is to evaluate the effectiveness of adding Blood Flow Restriction (BFR) therapy to a standardized rehabilitation protocol in patients undergoing postoperative rehabilitation following anterior cruciate ligament (ACL) repair surgery.
The main questions it aims to answer are:
Does combining BFR therapy with a standardized rehabilitation protocol improve functional recovery compared to rehabilitation alone?
Does the addition of BFR therapy enhance muscle strength and reduce recovery time in patients after ACL repair surgery?
Participants will undergo their assigned rehabilitation protocol and will be assessed prior to and after the intervention to determine if the addition of BFR therapy to the standard rehabilitation programme significantly improves functional recovery, muscle strength, and overall rehabilitation outcomes following ACL repair surgery.
The main questions it aims to answer are:
Does combining BFR therapy with a standardized rehabilitation protocol improve functional recovery compared to rehabilitation alone?
Does the addition of BFR therapy enhance muscle strength and reduce recovery time in patients after ACL repair surgery?
Participants will undergo their assigned rehabilitation protocol and will be assessed prior to and after the intervention to determine if the addition of BFR therapy to the standard rehabilitation programme significantly improves functional recovery, muscle strength, and overall rehabilitation outcomes following ACL repair surgery.
Detailed Description:
Anterior Cruciate Ligament (ACL) reconstruction is a common surgical intervention following ligament rupture, particularly among athletes engaged in pivoting sports such as soccer, handball, volleyball, and skiing. Despite surgical advances, up to 35% of athletes fail to return to their pre-injury level within two years post-surgery, with factors such as fear of re-injury and neuromuscular deficits playing a significant role.
This randomized controlled trial evaluates the efficacy of integrating Blood Flow Restriction (BFR) therapy into standard rehabilitation protocols after ACL reconstruction. Participants aged 18-45 years, recovering from ACL surgery, will be randomized into two groups: a control group following the standard rehabilitation protocol and an experimental group combining BFR therapy with rehabilitation. BFR involves applying controlled vascular restriction to the proximal limb using automated devices during low-intensity resistance exercises, aiming to enhance strength and neuromuscular recovery safely.
The intervention spans 12 weeks, primarily focusing on the strength and neuromuscular control phase of rehabilitation. Outcomes will include measures of pain, fear of movement, functional performance, and readiness to return to sport. Evaluations will be conducted at baseline and at 2, 6 and 12 weeks post-surgery. The study seeks to determine whether BFR accelerates recovery, improves functional outcomes, and facilitates a safer, more effective return to athletic activities.
This randomized controlled trial evaluates the efficacy of integrating Blood Flow Restriction (BFR) therapy into standard rehabilitation protocols after ACL reconstruction. Participants aged 18-45 years, recovering from ACL surgery, will be randomized into two groups: a control group following the standard rehabilitation protocol and an experimental group combining BFR therapy with rehabilitation. BFR involves applying controlled vascular restriction to the proximal limb using automated devices during low-intensity resistance exercises, aiming to enhance strength and neuromuscular recovery safely.
The intervention spans 12 weeks, primarily focusing on the strength and neuromuscular control phase of rehabilitation. Outcomes will include measures of pain, fear of movement, functional performance, and readiness to return to sport. Evaluations will be conducted at baseline and at 2, 6 and 12 weeks post-surgery. The study seeks to determine whether BFR accelerates recovery, improves functional outcomes, and facilitates a safer, more effective return to athletic activities.
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?: