Blood Flow Restriction Training in Knee Arthropathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorYuxiu Ji
About this trial
Arthrogenic muscle inhibition (AMI) is the key neurophysiological cause of impeding quadriceps activation following anterior cruciate ligament reconstruction (ACLR). Blood flow restriction training (BFRT) may induce neuroplasticity whereas the neurophysiological responses remain uncertain. In this study, we aimed to explore the effects of constant pressure blood flow restriction training (CP-BFRT) on neurophysiological responses and physical function. Patients will receive the same standardized progressive physical rehabilitation for 2 weeks after the surgery and then start the BRFT or sham BRFT intervention for the following 12 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Knee arthroscopy;
Age 18-60 years;
Ability to provide informed consent;
Availability for follow-up assessments;
Disqualifiers
Neurological disorders affecting lower extremity function;
Vascular disease or coagulopathy;
Contralateral knee pathology;
Previous knee surgery;
Trial design
Design model
Parallel
Treatments tested in this trial
Blood flow restriction training with 60%-80% occlusion
Other interventionA personalized constant-pressure system served as the active BFRT unit, with restrictive pressure set at 60%-80% of limb arterial occlusion pressure; it auto-inflates to maintain constant pressure and automatically monitors, assesses, and adjusts pressure during training.
Standard postoperative knee rehabilitation with sham BFRT
Other interventionStandard postoperative rehabilitation protocol after knee arthroscopic surgery, without blood flow restriction training. The rehabilitation program includes range of motion exercises, muscle strength training, balance training and functional activity training, with the same schedule, frequency and duration as the experimental group.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Blood flow restriction training groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
H-reflex Hmax/Mmax Ratio
H-reflex is a validated neurophysiological indicator for evaluating spinal-level AMI after knee surgery which is applied to assess resting spinal reflex excitability of the knee extensor motor pool vastus medialis. Unit of Measure: Ratio (dimensionless)
Time frame
From enrollment to the end of treatment at 12 weeks.Secondary outcomes
1
Knee Joint Position Sense (JPS) Accuracy
Knee proprioceptive acuity was evaluated using a calibrated isokinetic dynamometer. Participants were blindfolded to exclude visual interference and seated with the tested lower limb securely strapped to the dynamometer lever arm. The knee was passively positioned at three target flexion angles (30°, 60°, and 90°). After passive positioning and a 3-second holding phase, participants actively reproduced the perceived target angle independently. Absolute angular error was calculated as the absolute discrepancy between the preset target angle and the actively reproduced angle. Unit of Measure: Degrees (°)
Time frame
From enrollment to the end of treatment at 12 weeks.2
Somatosensory Evoked Potential (SEP) P40 Latency
Cortical somatosensory afferent function was assessed via tibial nerve somatosensory evoked potentials (SEP). The P40 latency was defined as the time interval from stimulus onset to the occurrence of the P40 positive wave, representing the conduction efficiency and temporal characteristics of peripheral proprioceptive signals transmitting to the primary somatosensory cortex. Unit of Measure: Milliseconds (ms)
Time frame
From enrollment to the end of treatment at 12 weeks.3
Somatosensory Evoked Potential (SEP) N45-P40 Peak-to-peak Amplitude
Central sensory integration plasticity was assessed via tibial nerve somatosensory evoked potentials (SEP). The N45-P40 peak-to-peak amplitude was calculated to evaluate cortical sensory gain and central inhibitory/excitatory balance. Unit of Measure: Microvolts (μV)
Time frame
From enrollment to the end of treatment at 12 weeks.4
Quadriceps rapid torque development rate (RTD)
Quadriceps rapid torque development rate (RTD) was measured to quantify the efficiency of central motor unit recruitment and neuromuscular rapid-driving capability. Quadriceps RTD was calculated as the rate of torque increase within the early contraction phase, reflecting the recruitment efficacy of high-threshold type II muscle fibers and synchronous firing of motor units. Unit of Measure: Nm/s
Time frame
From enrollment to the end of treatment at 12 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yuxiu Ji
Lead sponsor
The Affiliated Hospital Of Southwest Medical University
Sponsor institution
Source ClinicalTrials.gov
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