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NCT Number: NCT07140796

Effects of Hip Blood Flow Restriction and Shockwave Therapy on Q-Angle and Plantar Pressure in Adults With Genu Varum

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged between 20 and 40 years
  • Diagnosed with genu varum (inter-knee distance ≥ 3 cm in standing position)
  • No pain or surgery history in lower extremities within the last 6 months
  • Able to walk independently without assistance
  • Provide written informed consent

Exclusion criteria

  • Neurological or musculoskeletal disorders affecting gait or posture
  • Current use of medication affecting musculoskeletal or circulatory function
  • Previous surgery on the spine, pelvis, or lower limbs
  • Contraindications to shockwave therapy or BFR training (e.g., thromboembolic - disorders, deep vein thrombosis, cancer, etc.)
  • Participation in other clinical trials within the past month

Treatment and study plan

Blood flow restriction training

Behavioral

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

Device

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.

Primary outcomes

  1. Plantar pressure Distribution

    Time frame: Baseline and 4 Weeks Post-intervention

    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.

Secondary outcomes

  1. Quadriceps Angle (Q-angle)

    Time frame: At Baseline and 4 Weeks After Each Intervention Period

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Park sungjin

CONTACT

[email protected]

82+ 010-4121-4209

Sponsors and collaborators

Lead sponsor

Sungjin Park

Other

Registry information

Official study title

"A Crossover Study Investigating the Effects of Gluteus Medius-Focused Blood Flow Restriction Training With or Without Radial Shockwave Therapy on Q-Angle and Plantar Pressure in Adults With Genu Varum"

Acronym: BFR-GVQ

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 26, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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