The Effects of a Proprioception-enhancing Assistive Orthosis on Balance and Joint Sense in Geriatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Postural Sway
研究概览
简要总结
This study investigates the effects of a proprioception-enhancing assistive orthosis on balance and joint sense in geriatric patients with age-related diseases. The study uses wearable devices that deliver vibration stimuli to improve proprioceptive feedback. A total of 20 participants will be enrolled in a 24-month, IRB-approved trial at Seoul National University Hospital. The study assesses functional balance and joint position sense before and after using the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age-related diseases affecting balance and joint sense, who meet two or more of the following criteria for sarcopenia:
- •Muscle strength: Handgrip strength < 28 kg (men), < 18 kg (women)
- •Physical performance: Short Physical Performance Battery (SPPB) ≤ 8 points
- •Muscle mass: Bioimpedance analysis showing < 7.0 kg/m² (men), < 5.7 kg/m² (women)
- •Able to fully understand and follow instructions related to walking, sitting, and balance.
排除标准
- •Unable or unwilling to provide informed consent
- •High risk of falls due to severe visual impairment or dizziness
- •Communication difficulties due to speech, language, or hearing problems
- •Inability to walk independently without assistive devices
- •History of diseases affecting gait, efficiency, or endurance, such as:
- •Neurological disorders (e.g., stroke, Parkinson's disease)
- •Musculoskeletal disorders affecting the lower limbs
- •History of major orthopedic surgery on the lower limbs
- •Severe back pain or musculoskeletal pain affecting gait
- •Cardiovascular disease including heart failure or uncontrolled hypertension
- •Pulmonary diseases requiring regular oxygen therapy
- •Cancer requiring treatment within the past 3 years (except for non-melanoma skin cancer or early-stage breast/prostate cancer)
- •Psychiatric disorders such as schizophrenia, other psychoses, or bipolar disorder
- •Any other disease that significantly limits mobility
研究组 & 干预措施
Proprioception-Enhancing Orthosis
Geriatric patients with age-related diseases will undergo three assessment phases: (1) without the orthosis, (2) with the orthosis worn but vibration inactive, and (3) with the orthosis worn and vibration active.
干预措施: proprioception-enhancing assistive orthosis (Device)
结局指标
主要结局
Postural Sway
时间窗: up to 2 weeks
This measures the amount of body sway during quiet standing (static) or controlled leaning in various directions (dynamic). Parameters such as center of pressure (COP) displacement, velocity, and area are recorded to assess balance stability. Assessments will be conducted under the following three conditions: 1. without the orthosis, 2. with the orthosis worn but vibration inactive, and 3. with the orthosis worn and vibration active.
次要结局
- Berg Balance Scale(up to 2 weeks)
- Romberg Test(up to 2 weeks)
- Passive Joint Position Reproduction Test (Passive JPR)(up to 4 weeks)
- Active Joint Position Reproduction Test (Active JPR)(up to 4 weeks)
- Threshold to Detection of Passive Motion (TTDPM)(up to 4 weeks)