RecruitingNot ApplicableNCT06727344

Conservative Treatment With Blood Flow Restriction in Patients With Total ACL Rupture. "Randomized Clinical Trial"

Comparison of Conservative Treatment With Blood Flow Restriction With Standard Management in Total ACL Rupture. "Randomized Clinical Trial"


Sponsor

European University Cyprus

Enrollment

20 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomised clinical trial is to evaluate the effects of exercise with blood flow restriction (BFR) in patients with a complete anterior cruciate ligament (ACL) rupture. The main questions it aims to answer are: 1. Does blood flow restriction adds any additional benefits to conservative treatment of the ACL? 2. Does bracing promotes spontaneous healing to the ACL Researchers will compare bracing and BFR to bracing and sham BFR to see if the intervention provides any additional benefits to the conservative management of this injury. Participants will: 1. Use a knee brace for 6 weeks with adjustments according to protocol 2. Follow and identical exercise plan with either BFR (intervention group) or BFR sham (control group) 3. Follow a home based exercise program.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria1

  • MRI-confirmed complete rupture of ACL. Ability to communicate and read fluently in Greek and be willing to keep their leg immobilised for the required period based on the study protocol.

Exclusion Criteria1

  • Heart disease, overweight, diabetes, pregnancy, thrombophilia, atrial fibrillation, heart failure, cancer, use of drugs that may increase blood clotting, use of hormones or contraceptives, any reason for not using BFR e.g., an open wound or serious skin problems and/or allergies to the cuff material.

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Interventions

OTHERBlood Flow Restriction

Exercise with restriction of blood flow supply

OTHERBrace

Knee brace to restrict range of motion


Locations(2)

European University Cyprus

Nicosia, Cyprus

European University Cyprus

Nicosia, Cyprus

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NCT06727344


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