"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"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Plantar pressure Distribution
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BFR Only
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.
干预措施: Blood Flow Restriction Training (Behavioral)
BFR Only
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.
干预措施: Radial Extracorporeal Shockwave Therapy (Device)
BFR + Shockwave
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.
干预措施: Blood Flow Restriction Training (Behavioral)
结局指标
主要结局
Plantar pressure Distribution
时间窗: 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.
次要结局
- Quadriceps Angle (Q-angle)(At Baseline and 4 Weeks After Each Intervention Period)
研究者
Sungjin Park
Principal Investigator
Sahmyook University