The effects of Blood Flow Restriction training on Quadriceps Femoris and Hamstring isokinetic muscles strength, pain, function and proprioception in patients with knee osteoarthritis after total knee arthroplasty

Our aim is to investigate the effect of exercise with blood flow restriction on increasing the strength of the quadriceps femoris and hamstring muscles, proprioception, pain, and functional tests after knee joint replacement surgery.

Clinical trial with intervention and control group (parallel groups), single-blind, randomized, on 24 patients. Randomization will be done by Permuted block randomization method.

The participants are treated in the physiotherapy clinic of Iran Faculty of Rehabilitation Sciences for 2 weeks (10 sessions). The main variables of both groups are measured before treatment, after treatment and 2 weeks after treatment. In this clinical trial or RCT, the evaluator and the therapist are two different people. Therefore, this study is a single-blind study.

Inclusion criteria: The patient has undergone knee joint replacement surgery at least 14 days before. The patient's age is over 60 years. The patient's knee pain should be reported as higher than 3 based on the VAS criterion in the last week. The patient should be able to walk 6 meters and above. The patient must consent to the study. Non-entry criteria: Any peripheral and central nervous system disease. Uncontrolled cardiovascular disease. Open fractures and dislocations of the lower limbs, back and pelvis. History of chemotherapy and radiotherapy and active neoplasm.

In the intervention group, the cuff of the Blood Flow Restriction device is attached above the patient's knee and pressure is applied and the patient performs the exercises. In the control group, only the cuff is attached for the patient, but no pressure is applied and the patient performs the same exercises as the intervention group.

Isokinetic strength of quadriceps femoris and hamstring muscle, pain, function and knee proprioception

Allocation of patients to intervention and control groups is done by random block allocation method. The allocation sequence is generated using the free web system at randomization.com, in which the block size of 4 and the number of blocks of 6 were considered in this method. 24 numbers are considered for each case. The software defines 6 blocks of 4 that out of 4, 2 people enter the exercise training group with BFR and 2 people enter the exercise training group with Sham BFR, thus 24 people are completed. Random allocation is done with a ratio of 1 to 1. Non-transparent and sealed envelopes will be used to hide the allocation of patients to groups.

In this clinical trial or RCT, the evaluator and the therapist are two different people. Therefore, this study is a single-blind study. Also, the statistical analyst is not aware of the grouping.