The Effect of Single-leg 20-degree Squats Combined With Conventional Training on the Biomechanical Characteristics of Gait After Anterior Cruciate Ligament Reconstruction Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPeking University Third Hospital

About this trial

Anterior cruciate ligament (ACL) tears are one of the most common sports injuries, with an ACL injury rate as high as 20.9% in the general population . Currently, the primary treatment for ACL tears is arthroscopic reconstruction surgery to restore knee stability and function . Following ACL injury, abnormal gait biomechanical characteristics persist, even after ACL reconstruction surgery (ACLR) and evidence-based rehabilitation therapy. These abnormal gait biomechanical characteristics remain unresolved, with the lower limbs exhibiting insufficient loading and stiffness, which are associated with quadriceps muscle dysfunction. Interventions for quadriceps atrophy following ACLR should be initiated early to prevent worsening of early knee pain, swelling, and abnormal gait. Additionally, since ACL reconstruction results in different biomechanical characteristics at various stages and gait phases, it is important to adopt more targeted and precise rehabilitation measures to correct biomechanical abnormalities and improve gait function in patients.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Clinical diagnosis of unilateral Anterior Cruciate Ligament (ACL) rupture.

Aged between 18 and 45 years.

Scheduled for primary unilateral ACL reconstruction at our hospital.

Presence of quadriceps atrophy, defined as the bilateral difference in quadriceps strength is >10% of the contralateral unaffected limb.

Disqualifiers

Severe injury (Grade II or III) to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament in the affected knee.

Concomitant severe meniscal tear(s) in the affected knee.

History of significant prior trauma or surgery to the affected knee.

Presence of other knee joint diseases (e.g., osteoarthritis, tumors, rheumatoid arthritis, tuberculosis).

Trial design

Design model

Parallel

Treatments tested in this trial

  • single-leg 20° squat training

    Behavioral

    Both groups underwent conventional training. In addition, the experimental group underwent single-leg 20° squat training. Participants were required to stand for the exercise and hold onto a stable surface with their hands, while the unaffected lower limb hip joint was extended and the knee joint flexed to 90°. Participants were then instructed to bend the affected knee to 20° and hold this position for 10 seconds. They then fully extended the knee and rested in that position for 3-4 seconds. The load form can be dumbbells.

  • regular training

    Behavioral

    In the 1-8 week rehabilitation program, the goal is to strengthen the muscle strength of the affected knee joint and gradually introduce functional movement exercises, while avoiding forceful flexion and extension of the knee. The specific rehabilitation program includes: prone leg curl exercises, quadriceps resistance band training, hamstring progressive resistance exercises, backward lunge exercises, in-place small jumps, knee joint flexion with appropriate cushioning, in-place squat jumps, landing and immediately squatting for stability, repeated 15 times, each lasting 2-3 seconds, performed 2-3 sets per week, totaling 3 sessions; Wall-supported static squat exercises, repeated 5 times, performed 2-3 sets per week, totaling 3 sessions.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: experimental groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Knee joint kinematics during walking

Kinematic angles (flexion, rotation, and adduction) of the knee joint in the sagittal, frontal, and horizontal planes during walking.

Time frame
Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)
2

Knee joint kinetics during walking

The moment generated at the knee joint during walking.

Time frame
Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)]
3

Gait-Synchronized Electromyographic Signals

Outcome Measure 1: Raw electromyographic (EMG) activity Raw EMG signals of the rectus femoris, vastus lateralis, vastus medialis, biceps femoris, and semitendinosus muscles during specified movements. Outcome Measure 2: Integrated electromyographic (IEMG) activity The integrated EMG (IEMG) of the rectus femoris, vastus lateralis, vastus medialis, biceps femoris, and semitendinosus muscles during specified movements. Outcome Measure 3: Average electromyographic (AEMG) amplitude The average EMG amplitude (AEMG) of the rectus femoris, vastus lateralis, vastus medialis, biceps femoris, and semitendinosus muscles during specified movements.

Time frame
Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)]
4

Isokinetic muscle strength

Quadriceps isokinetic strength test: Isokinetic biomechanical test and trainer (CON-TREX, MJ; Germany), conducted by the same tester on a constant velocity device. Three complete movements need to be collected, with an interval of 90 seconds between each test to avoid fatigue. The quadriceps muscle was tested for isokinetic and eccentric peak torque (PT) at 60°/s.

Time frame
Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)

Secondary outcomes

1

Lysholm Knee Scoring Scale

The Lysholm Knee Scoring Scale, a patient-reported outcome measure assessing knee function. Scores range from 0 to 100, where higher scores indicate a better outcome.

Time frame
Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)]
2

International Knee Documentation Committee Subjective Knee Form

The International Knee Documentation Committee Subjective Knee Form, a patient-reported outcome measure assessing symptoms, function, and sports activity. Scores range from 0 to 100, where higher scores indicate a better outcome.

Time frame
Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)
3

Thigh circumference measurement

The circumference of the thigh, measured at a standardized anatomical location, to assess muscle atrophy or swelling. A smaller circumference indicates a worse outcome (greater atrophy or reduced swelling).

Time frame
Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)

Other outcomes

Locations

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