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

NCT07140796 | Not Yet Recruiting

• 2 other identifiers: SYU 2025-06-031-001Sahmyook University
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Genu Varum

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 4 Weeks Post-intervention

Secondary Outcomes (1)

• Quadriceps Angle (Q-angle)

  At Baseline and 4 Weeks After Each Intervention Period

Study Arms (2)

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.

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.

Behavioral: Blood Flow Restriction Training

Interventions

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.

BFR + Shockwave; BFR Only

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.

BFR Only

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sungjin Park: lead

Study Sites (1)

Gangnam Su Rehabilitation Medicine Manual & Exercise Therapy Center

Seoul, Seoul, 06606, South Korea

Location

MeSH Terms

Conditions

Genu Varum

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Park sungjin

CONTACT

82+ 010-4121-4209; 0803pak@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 26, 2025
• Study Start: September 10, 2025
• Primary Completion: September 10, 2025
• Study Completion: January 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)