Genu VarumBFR-GVQNCT07140796
Effects of Hip Blood Flow Restriction and Shockwave Therapy on Q-Angle and Plantar Pressure in Adults With Genu Varum
A study testing Blood Flow Restriction Training and Radial Extracorporeal Shockwave Therapy in people with Genu Varum, run by Sungjin Park at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Genu Varum
- What is being tested?
- Blood Flow Restriction Training and Radial Extracorporeal Shockwave Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Sep 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Gangnam Su Rehabilitation Medicine Manual & Exercise Therapy Center
Seoul, Seoul, 06606
sungjin Park, +82-010-4121-4209, 0803pak@naver.com
About this study
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"
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.
Read the 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.
- Conditions
- Genu Varum
- Being tested
- Blood Flow Restriction Training, Radial Extracorporeal Shockwave Therapy
- Keywords
- Genu varum, Blood Flow Restriction, BFR Training, Radial Shockwave Therapy, Q-angle, Plantar pressure
- Medical subject headings
- Genu Varum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction TrainingBehavioural
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BFR Only | Experimental | 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. Receives: Behavioral: Blood Flow Restriction Training; Device: Radial Extracorporeal Shockwave Therapy |
| BFR + Shockwave | Experimental | 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. Receives: Behavioral: Blood Flow Restriction Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 Weeks Post-intervention
Secondary outcomes (1)
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.
Measured: At Baseline and 4 Weeks After Each Intervention Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start10 Sep 2025 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genu VarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sungjin Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sungjin Park, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140796
- Sponsor's protocol ID
- SYU 2025-06-031-001
- Other IDs
- Sahmyook University
- Acronym
- BFR-GVQ
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "IPD will not be shared because the data are limited to a small sample of clinical patients and involve privacy-sensitive health information."
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT07140796
- Acronym / sponsor ID
- BFR-GVQ / SYU 2025-06-031-001
- Conditions
- Genu Varum
- Keywords
- Genu varum, Blood Flow Restriction, BFR Training, Radial Shockwave Therapy, Q-angle, Plantar pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Sungjin ParkUniversity, hospital or other
- Study start
- 10 Sep 2025 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BFR Only | Experimental | Behavioral: Blood Flow Restriction Training, Device: Radial Extracorporeal Shockwave TherapyParticipants 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. |
| BFR + Shockwave | Experimental | Behavioral: Blood Flow Restriction TrainingParticipants 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction TrainingParticipants 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. | Behavioural | BFR + Shockwave, BFR Only |
| Radial Extracorporeal Shockwave TherapyRadial 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. | Device | BFR Only |
Primary outcome
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.
1 secondary outcome
Quadriceps Angle (Q-angle)
Time frame: At Baseline and 4 Weeks After Each Intervention Period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Training and Radial Extracorporeal Shockwave Therapy in people with Genu Varum, run by Sungjin Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Park sungjin (82+ 010-4121-4209, 0803pak@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plantar pressure Distribution (time frame: Baseline and 4 Weeks Post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.