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Not yet recruiting NCT07140796

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

No phase Interventional Genu Varum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood Flow Restriction Training, Radial Extracorporeal Shockwave Therapy.
Who it may be relevant to
Registry conditions: Genu Varum. Basic parameters: 20 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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"

Overview

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.

Detailed description

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.

Interventions

  • 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.
  • Device Radial Extracorporeal Shockwave Therapy
    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 outcome measures

  • Plantar pressure Distribution [Time frame: Baseline and 4 Weeks Post-intervention]
Secondary outcome measures (1)
  • Quadriceps Angle (Q-angle) [Time frame: At Baseline and 4 Weeks After Each Intervention Period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Gangnam Su Rehabilitation Medicine Manual & Exercise Therapy Center — Seoul

Identifiers

NCT: NCT07140796 · SYU 2025-06-031-001 · Sahmyook University

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗