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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07140796
Acronym
BFR-GVQ
Enrollment
14
Registered
2025-08-26
Start date
2025-09-10
Completion date
2026-01-01
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genu Varum

Keywords

Genu varum, Blood Flow Restriction, BFR Training, Radial Shockwave Therapy, Q-angle, Plantar pressure

Brief summary

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

BEHAVIORALBlood 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.

Sponsors

Sungjin Park
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Masking description

This study is open label because both the participants and investigators are aware of the intervention being administered. Due to the physical nature of the interventions (exercise and shockwave therapy), blinding was not feasible.

Intervention model description

This study uses a crossover design in which each participant receives two different interventions-gluteus medius-focused blood flow restriction (BFR) training alone and BFR training combined with radial extracorporeal shockwave therapy (rESWT)-in randomized order, with a washout period between the phases.

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Plantar pressure DistributionBaseline and 4 Weeks Post-interventionPlantar 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

MeasureTime frameDescription
Quadriceps Angle (Q-angle)At Baseline and 4 Weeks After Each Intervention PeriodQ-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.

Countries

South Korea

Contacts

Primary ContactPark sungjin
0803pak@naver.com82+ 010-4121-4209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026