NCT06387459招募中不适用
Safety and Feasibility of Knee Extensor Muscle-mimicking, Fabric-type Orthosis on Gait in Geriatric Patients: Pilot Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Completion Rate
研究概览
简要总结
This pilot clinical trial assesses the safety and feasibility of a novel fabric-type orthosis designed to mimic the knee extensor muscles and improve gait in elderly patients with mobility impairments due to conditions like sarcopenia, diabetes, or knee osteoarthritis. The study aims to test this orthosis in a real- world setting to see if it can enhance mobility and stability for elderly individuals, potentially reducing falls and improving quality of life. A total of 30 participants aged 65 and older will be recruited to use this orthosis across multiple sessions, where their gait will be analyzed under various conditions to measure the device's impact on walking speed, stability, and muscle activation.
详细描述
Objectives:
- Primary Objective: To evaluate the safety and feasibility of the fabric-type knee extensor muscle-mimicking orthosis in improving gait among elderly patients.
- Secondary Objectives: To measure changes in walking speed, endurance, and muscle activity to infer potential benefits in daily mobility.
Study Design:
- Study Population: 30 elderly patients suffering from conditions affecting mobility (sarcopenia, diabetes, knee osteoarthritis).
- Intervention: Use of a fabric-type orthosis mimicking knee extensor function, equipped with shape-memory alloy for dynamic movement support.
- Methodology:
- Training and Adaptation: Participants will undergo an initial training session to get accustomed to the orthosis, including donning and doffing, adjustment, and use in various environments (flat surfaces, inclines).
- Assessment Protocol:
- Before wearing the orthosis-after wearing the orthosis (power off)-after wearing the orthosis (power on)
- Walking environment will include EMG (Electromyography) measurements, 6-minute walk test, 10-meter walk test, and comprehensive gait analysis using platforms like the GAITRite system.
- Seating environment will include EMG (Electromyography) measurements and TUG test. 3. Safety Monitoring: Continuous monitoring of physiological responses (blood pressure, heart rate), musculoskeletal assessments, and skin integrity checks to monitor for adverse reactions or discomfort
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
- •Eligibility for participation in the study requires that all the following criteria are met:
- •Age: Participants must be 65 years of age or older.
- •Comprehension and Compliance: Able to fully understand and comply with the instructions and study procedures.
- •Mobility-Impacting Conditions: Must have at least one of the following conditions affecting mobility: (1)Sarcopenia:
- •Muscle Strength: Handgrip strength of <28 kg for men and <18 kg for women.
- •Muscle Function: Short Physical Performance Battery (SPPB) score of 8 or less.
- •Muscle Mass: Bioelectrical impedance analysis (BIA) showing muscle mass <7.0 kg/m² for men and <5.7 kg/m² for women. (2)Diabetes:
- •Diagnosed distal symmetric polyneuropathy.
- •Sensory impairments in toes or feet. (3)Knee Osteoarthritis:
- •Kellgren-Lawrence grade ≥
- •Persistent pain (≥3 months) with a severity of at least 3 on the Numerical Rating Scale (NRS).
排除标准
- •Individuals meeting any of the following criteria will be excluded from study participation:
- •Inability to Consent: Unable to provide informed consent or not willing to participate in the study procedures.
- •Severe Sensory or Motion Limitations: Including severe visual or vestibular impairments that could increase the risk of falling.
- •Communication Barriers: Significant hearing, speech, or language problems that would hinder communication with study personnel.
- •Independent Walking Inability: Cannot walk independently without the aid of a walking device.
- •Other Significant Diseases or Conditions:
- •Neurological disorders that affect walking ability (e.g., stroke, Parkinson's disease).
- •Orthopedic or musculoskeletal conditions severely affecting lower limb function.
- •Severe cardiovascular conditions including uncontrolled hypertension or heart failure.
- •Respiratory diseases requiring regular oxygen therapy.
- •Active cancer treatment or cancer treatment within the past 3 years (except basal cell carcinoma or localized prostate cancer).
- •Severe psychiatric disorders like schizophrenia or bipolar disorder.
- •Other Exclusionary Factors:
- •Past severe orthopedic surgeries on lower limbs which might affect gait and mobility.
- •Severe back pain or any other condition affecting mobility not already listed.
结局指标
主要结局
Completion Rate
时间窗: 1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)
The proportion of participants who complete the study as per the protocol, which indicates the orthosis's acceptability and the study's overall manageability.
次要结局
- Dropout Rate(1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on))
- 10-Meter Walk Test(1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on))
- User Feedback(1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on))
- 6-Minute Walk Test(1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on))
- Surface Electromyography(1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on))
- Gait Analysis(1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on))
研究者
研究点 (2)
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