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

March 29, 2025 updated by: Alexios Pitsillides, European University Cyprus

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Methodological design:

For the purposes of the present study, a double-blind, two-arm randomised clinical trial will be conducted. Participants in the intervention group will undergo and exercise protocol with the use of blood flow restriction (BFR). Participants in control group will follow the same exercise protocol but with sham BFR instead. Both groups will follow the same brace protocol.

Intervention group:

The intervention group will consist of people with a recent ACL tear who meet the eligibility criteria. Participants in this group will follow a splint use protocol. In particular, during the first 3 weeks (phase 1) a splint will be used with the knee immobilised at 90°, non-weight bearing walking with the use of walking aids according to age and mobility. During the 4th and 5th week (phase 2) the range of motion of the splint will be set to 60° to 90° and from 30° to 90° respectively. Walking will remain non-weight bearing. During the 6th week (phase 3) the degree of freedom of the splint will be placed at 0° allowing full flexion but preventing hyperextension of the joint. During this phase, partial bearing is allowed with the use of a walking aid. From the 7th week (phase 4) onwards the splint is removed and walking is done with no loading restrictions.

Regarding the exercise program, participants in this group, during phase 1, will perform isometric quadriceps and hamstring contractions guided by a visual stimulus from an electronic hand dynamometer. The exercise parameters will be 75 repetitions divided into 4 sets (30,15,15,15) at 30% of the 1st maximum of the opposite leg. During phase 2, the exercise protocol is maintained as phase 1 with the only differences that the exercises will be performed at 60 degrees too. Additionally, the "sliding" exercise will be added where the heel is dragged on the bed causing knee flexion as well as the skateboard sliding exercise from a seated position in the allowed range of motion. Exercise parameters remain the same for all exercises as previous phase. In the 3rd phase, single leg squats up to 45° are added. Exercise parameters remain the same. In the 4th phase, the exercise protocol changes. Subjects start at a stationary bike for 5 minutes (without BFR) and the quadriceps and hamstrings isometrics are replaced with resistance exercises for extension and knee flexion. Sliding and single-leg squats are performed at an increased range of flexion (up to 90°) and climbing a 30cm step is added. All exercise parameters remain the same as in the previous phases. During the last phase (5th) gait retraining on a treadmill for 5 minutes and Y balance exercise is added. Both of these exercises will be performed without BFR. The break between sets will be 30 seconds and between exercises 1 minute.

The exercise program of the intervention group will be performed under lower extremity blood flow restriction. Cuff pressure will be reduced during the breaks. The execution speed of the exercises will be 2 seconds of contraction followed by 2 seconds of return. Hold in all isometric exercises will be 3 seconds.

Initial measurements will be taken upon enrollment of participants and will include MRI, Lachman test, arthrometer, strength, swelling, Lysholm scale, Tegner scale, pain (Vas), exercise pain (Vas). By the end of 2nd and 4th week, strength, swelling and pain (Vas) will be reassessed. The final measurements will be taken at the end of the intervention period and will include all the measurements taken initially.

The participants will be given a home-base exercise program through an electronic platform which will provide the possibility of monitoring their compliance. At the same time, through the platform, the correct execution of the exercises will be ensured as all the exercises will be presented with videos and specific exercise parameters.

Control Group:

The control group will perform an identical program of splinting, exercises, home exercises and measurements as the intervention group. The blood flow restriction protocol will be performed in an identical manner to the intervention group, with only difference being that variables setting will be set at a control program (sham).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Cyprus
      • Nicosia, Cyprus, 2404
        • Recruiting
        • European University Cyprus
        • Contact:
        • Contact:
          • Alexis Pitsillides, Phd candidate
        • Contact:
          • Antonis Konstantinou, Phd
        • Contact:
          • Christos Karagiannis, PhD
        • Contact:
          • Konstantinos Giannakou, PhD
        • Contact:
          • Kyriakos Pavlou, PhD candidate
        • Contact:
          • Theognosia Panteli, PhD Cand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brace and BFR exercise
Other: Blood Flow Restriction
Exercise with restriction of blood flow supply
Other: Brace
Knee brace to restrict range of motion
Sham Comparator: Brace and BFR sham
Other: Brace
Knee brace to restrict range of motion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength
Time Frame: Enrolment, week 2 and 4, end of intervention (12 weeks)
Quadriceps strength using a hand held dynamometer
Enrolment, week 2 and 4, end of intervention (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI
Time Frame: Enrolment and end of intervention at 12 weeks
Enrolment and end of intervention at 12 weeks
Knee laxity
Time Frame: enrolment and end of intervention at 12 weeks
Knee arthrometer
enrolment and end of intervention at 12 weeks
Balance
Time Frame: enrolment and end of intervention at 12 weeks
Star execution test
enrolment and end of intervention at 12 weeks
Swelling
Time Frame: enrolment and end of intervention at 12 weeks
Knee circumference
enrolment and end of intervention at 12 weeks
Visual analog scale (VAS)
Time Frame: enrolment, week 2 and 4 and end of intervention at 12 weeks
Visual analog scale for pain measurement. A higher score indicates greater pain intensity 0 indicates no pain while 100 indicates the worst pain.
enrolment, week 2 and 4 and end of intervention at 12 weeks
Lysholm scale
Time Frame: enrolment and end of intervention at 12 weeks
Lysholm scale: The Lysholm Knee Score is a questionnaire consisting of 8 items. The scale calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. A high score on the Lysholm score list corresponds to a low degree of knee instability.
enrolment and end of intervention at 12 weeks
Patient reported outcome measures
Time Frame: enrolment and end of intervention at 12 weeks

Tegner scale:

The TAS is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes.
enrolment and end of intervention at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European University Cyprus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

November 30, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 29, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ΕΕΒΚ/ΕΠ/2024/70

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To keep the study double blinded

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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