Customized Self-Controlled Power-Driven or Mechanical Orthoses for the Upper Limb - A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Patients' Satisfaction Score
研究概览
简要总结
Patients with congenital or acquired upper limb structural abnormalities and peripheral nerve or brachial plexus palsies have significant loss of function. The use of orthoses may improve function particularly in performing specific tasks for which the orthoses are designed, depending on the patients' deficiencies and needs. The performance of orthoses may be enhanced by being light-weight, motor-driven, and ergonomic.
This pilot, prospective study is designed to test the feasibility and effectiveness of the specially designed orthoses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with any congenital or acquired upper limb structural abnormalities
- •Patients' condition is not suitable for surgical intervention or patients are not keen for surgical treatment
排除标准
- •Patients have no available muscle signal input
- •Patients fitted with a pacemaker or an implantable cardioverter defibrillator (ICD) or other implantable electrical devices
- •Patients with contact dermatitis
研究组 & 干预措施
Orthoses
Only one single arm in this study
干预措施: Orthoses (Device)
结局指标
主要结局
Patients' Satisfaction Score
时间窗: 1-week after
To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)
Disability of Arm, Shoulder and Hand (DASH) questionnaire
时间窗: 1-week after
Specially designed tool to assess upper extremity disability and symptoms
Grip Strength
时间窗: 1-week after
Will be measured in kg
Visual Analogue Scale (VAS) Pain Score
时间窗: 1-week after
VAS pain score will be measured
Short-Form Survey (SF-36)
时间窗: 1-week after
Generic health status instrument to assess quality of life
Active and passive range of motion (ROM)
时间窗: 1-week after
ROM will be measured to determine the joint stiffness
Patients' Satisfaction Score
时间窗: Baseline
To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)
Visual Analogue Scale (VAS) Pain Score
时间窗: Baseline
VAS pain score will be measured
Short-Form Survey (SF-36)
时间窗: Baseline
Generic health status instrument to assess quality of life
Active and passive range of motion (ROM)
时间窗: Baseline
ROM will be measured to determine the joint stiffness
Disability of Arm, Shoulder and Hand (DASH) questionnaire
时间窗: Baseline
Specially designed tool to assess upper extremity disability and symptoms
Grip Strength
时间窗: Baseline
Will be measured in kg
次要结局
未报告次要终点
研究者
Michael Chu Kay MAK
Associate Consultant and Clinical Assistant Professor (Honorary)
Chinese University of Hong Kong