MOTU++ - Studio Clinico Protesi
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Ad hoc check list for Adverse Event
研究概览
简要总结
The aim of the present study is to verify the functionalitỳ, the degree of safety and the reliability of devices composed of an intelligent socket that allows the detection of biosignals and provides vibrotactile feedback and a prosthesis with active knee and ankle joints and a sensorised foot, for people with trans-femoral or trans-tibial amputation, which allows the optimisation of the gait cycle by providing active assistance at the knee and ankle joints according to the specific movement made by the user. The prototype devices are innovative in that they make it possible to optimise the benefits generated by the presence of actuated joints by exploiting the biosignals detected to ensure optimal functionalitỳ in the performance of activities̀ of daily living.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years;
- •Lower limb amputation at the transfemoral or transtibial level;
- •Functional medical classification: Level K3-K4 [25];
- •Subjects wearing a prosthesis for at least 1 year (experienced wearers);
- •Maximum body weight 100 kg.
排除标准
- •Significant medical comorbidities: Presence of severe neurological disorders, cardiovascular diseases, uncontrolled diabetes/hypertension, or severe sensory deficits.
- •Implanted cardiac devices: Individuals with implanted pacemakers or cardioverter-defibrillators.
- •Cognitive impairment: Individuals with a Mini-Mental State Examination (MMSE) score less than 24, adjusted for age and education, indicating cognitive impairment that may compromise understanding of instructions and research participation.
- •Severe depressive symptoms: Individuals with a Beck Depression Inventory-II (BDI-II) score less than 19, indicating clinically significant depression that may affect motivation and participation in the research.
- •Severe anxiety symptoms: Individuals with a State-Trait Anxiety Inventory (STAI-Y) score less than 50, indicating clinically significant anxiety that may interfere with research participation.
- •Inability or unwillingness to provide informed consent: Individuals who are unable to understand or provide informed consent to participate in the research, or who refuse to participate.
结局指标
主要结局
Ad hoc check list for Adverse Event
时间窗: day 6
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
次要结局
- 10mwt - 10 meters walking test(day 4)
- Borg Scale(day 5)
- 6mwt - 6 minutes walking test(day 6)
- System Usability Scale(day 6.)
- TUG - Time Up and Go(day 4)
- SCT - Stair Climbing Test(day 4)
- FCT - Functional Reach Test(baseline)
- Functional Reach Test(day 5)
- Cost of Transport -COT(day 6)