Myoelectric and Bionic Hands in Upper Limb Amputations: A Comparison of Body Image, Function and User Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Upper Limb Functionol Index-15
研究概览
简要总结
This observational study aims to compare myoelectric and bionic hands in terms of upper extremity function, body image and satisfaction.
The main questions it aims to answer are:
- Does upper extremity function differ between bionic and myoelectric hands?
The main questions it aims to answer are:
Does upper extremity function differ between bionic and myoelectric hands?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years
- •Individuals with unilateral upper limb amputation
- •Regular use of a prosthetic device for at least 6 months
- •Use of a semi-electronic elbow joint prosthetic component
- •Ability to understand and complete study assessments
排除标准
- •Presence of bilateral or multiple limb amputations
- •Proximal upper limb amputation at the shoulder level or above
- •Coexisting neurological or orthopedic disorders that may affect upper limb function or study outcomes
研究组 & 干预措施
Bionic Prosthetic Hand Group
Participants use advanced myoelectric prosthetic hands with multi-articulating structures and enhanced control features designed to improve functional performance.These devices are designed to enhance hand function, dexterity, and user interaction beyond conventional myoelectric control.
Myoelectric Prosthetic Hand Group
Participants in this group are individuals with upper limb amputation who use a myoelectric prosthetic hand controlled by surface electromyographic signals from residual limb muscles. These devices provide electrically powered hand movement and basic grasp functions without advanced bionic or sensor-integrated features.
结局指标
主要结局
Upper Limb Functionol Index-15
时间窗: Baseline
The Upper Limb Functional Index-15 (ULFI-15) is a 15-item patient-reported outcome measure used to assess functional limitations related to the upper extremity. It evaluates difficulties in daily activities, movement, and functional performance of the upper limb. Higher scores indicate greater functional limitation.
Amputee Body Image Scale
时间窗: Baseline
The Amputee Body Image Scale (ABIS) is a self-reported questionnaire designed to assess body image perception and body-related concerns in individuals with limb amputation. It measures the psychological impact of amputation on body image, with higher scores reflecting greater body image disturbance.
Orthotics and Prosthetics Users' Survey
时间窗: Baseline
The Orthotics and Prosthetics Users' Survey (OPUS) is a validated patient-reported outcome measure used to evaluate functional status, satisfaction, and quality of life in individuals using orthotic or prosthetic devices. It assesses the user's perceived functional ability and satisfaction with their prosthetic device and related services.
次要结局
未报告次要终点
研究者
Güllü Aydın Yağcıoğlu
Asst. Prof
Gulhane School of Medicine