Effects of 3D Printing Assistive Device on ADL Function in Patients With Nerve Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Active joint range of motion of shoulder and elbow
研究概览
简要总结
Our study is aimed to evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.
详细描述
Background: Injury to the central or peripheral nerves can lead to limited hand function and further affect the ability of daily life. The use of assistive devices can assist functional activities and reduce the phenomenon of non-use. 3D printing technology was used to construct personalized, complicated orthosis, and one piece to reduce assembly time. But the evidence most are product development, but few of study investigate the effectiveness and it cannot be widely used for hand injuries.
Aim: To evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.
Methods: Thirty neural injury patients were recruited and randomized into experimental (3D printing assistive device) or control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week). The performance was assessed by a blinded assessor included Active Range of motion (AROM), Box and block test, Grip dynamometer, upper extremity task, Disability of the arm, shoulder and hand questionnaire(DASH), General Health Questionnaire(GHQ-12) and Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). The practice performance and adverse effect were recorded. Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.
Keywords: Neural injury, 3D printing, assistive device, hand function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The medical record shows the diagnosis of central or peripheral nerve injury, and the onset is more than three months
- •Able to understand wearing operation instructions and have the ability to give informed consent
- •Able to control shoulder lifting and bending elbows, but difficult to grasp tools
排除标准
- •Older than 75 years old and younger than 20 years old
- •Severe visual or hearing impairment
- •Suffering from other neurological, cardiopulmonary, or musculoskeletal diseases that affect the subject to perform the actions required by this test.
结局指标
主要结局
Active joint range of motion of shoulder and elbow
时间窗: Change from Baseline at 2 weeks and 4 weeks
use a goniometer to measure the active joint movements of the shoulder and elbow, including shoulder flexion, abduction, external rotation , internal rotation, and elbow flexion angle.
次要结局
- Box and block test (BBT)(Change from Baseline at 2 weeks and 4 weeks)
- Grip power(Change from Baseline at 2 weeks and 4 weeks)
- Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)(Change from Baseline at 4 weeks)
- Daily wearing activity record sheet(Every training session during 8 sessions, total sessions continued to 4 weeks)
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)(The end of the study at 4 weeks)
- General Health Questionnaire (GHQ-12)(Change from Baseline at 4 weeks)
- Hand function tasks(Change from Baseline at 2 weeks and 4 weeks)