An interventional study of Blood Flow Restriction Training and Radial Extracorporeal Shockwave Therapy in Genu Varum, sponsored by Sungjin Park. Not yet recruiting at 1 site in South Korea. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Sungjin Park · Not applicable, Interventional, and Treatment
This study aims to investigate the effects of gluteus medius-focused blood flow restriction (BFR) training, with or without the addition of radial shockwave therapy, on lower limb alignment in adults with genu varum. The study uses a crossover design and evaluates changes in Q-angle(Quadriceps-angle) and plantar pressure as primary outcomes. All interventions are non-invasive and supervised, and the goal is to identify effective therapeutic strategies to improve biomechanical alignment in individuals with bowed legs.
This study investigates the effects of gluteus medius-focused blood flow restriction (BFR) training with or without radial extracorporeal shockwave therapy (rESWT) on lower limb alignment in adults with genu varum. Genu varum, commonly known as bow-leggedness, can lead to altered biomechanical patterns and increased stress on the medial knee joint. Strengthening the hip muscles, particularly the gluteus medius, may contribute to improved alignment and postural stability.
Participants will undergo two different intervention phases in a crossover design. Each phase includes a 4-week intervention period, with a 2-week washout in between. The primary outcome measures are Q-angle (quadriceps angle) and plantar pressure distribution, which will be assessed before and after each intervention phase using validated measurement tools.
This study aims to determine whether BFR training alone or combined with shockwave therapy provides greater improvement in lower limb alignment in individuals with genu varum. All interventions will be supervised, non-invasive, and conducted in a clinical setting under standardized conditions.
18 studies on the registry are indexed under Genu Varum; 8 are open to participants now.
This study's planned enrollment of 14 is below the median of 60 across 12 interventional studies indexed under Genu Varum.
Browse Genu Varum studies →This is the only study on the registry with Sungjin Park as lead sponsor.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Participants in this group will undergo blood flow restriction (BFR) training alone. BFR training will be performed using a thigh cuff at a pressure estimated based on the participant's thigh circumference and blood pressure. Squats will be performed with 15% of body weight and hip internal rotation at 15 degrees, twice per week for 4 weeks.
Behavioral: Blood Flow Restriction Training · Device: Radial Extracorporeal Shockwave Therapy
Participants in this group will receive a combination of blood flow restriction (BFR) training and radial extracorporeal shockwave therapy (rESWT). BFR training will be conducted as in the other arm. Additionally, rESWT will be applied to the gluteus medius region before each exercise session, with 2000 pulses per session, twice per week for 4 weeks.
Behavioral: Blood Flow Restriction Training
Participants perform squats with 15% of their body weight under blood flow restriction using a thigh cuff. Hip internal rotation is set at 15 degrees. The training is conducted twice a week for 4 weeks. Cuff pressure is estimated using a predictive formula based on thigh circumference and systolic blood pressure.
Radial extracorporeal shockwave therapy (rESWT) is applied to the gluteus medius region prior to each exercise session. The protocol includes 2000 pulses per session, applied twice per week for 4 weeks, using a radial shockwave device.
Plantar pressure Distribution
Plantar pressure will be assessed using the TPScan system while participants walk barefoot over the pressure mat. The system will analyze peak pressure, pressure-time integral, and center of pressure trajectory in both feet. Data will be collected under two conditions (BFR alone vs. BFR + rESWT), and compared to evaluate the effects of the intervention.
Time frame: Baseline and 4 Weeks Post-intervention
Quadriceps Angle (Q-angle)
Q-angle will be measured using a goniometer with participants in the supine position and legs extended. The angle is defined by the intersection between the line from the anterior superior iliac spine (ASIS) to the center of the patella, and the line from the patella to the tibial tuberosity. Data will be collected before and after each intervention to assess changes in lower limb alignment.
Time frame: At Baseline and 4 Weeks After Each Intervention Period
Plan to share: No — "IPD will not be shared because the data are limited to a small sample of clinical patients and involve privacy-sensitive health information."
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Start is estimated for Sep 2025; primary completion for Sep 2025, 0 months later.
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