A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Range Of Motion
研究概览
简要总结
The goal of this clinical trial is to evaluate the applicability, effectiveness, and usability of a shape memory alloy-based orthosis for patients with finger proximal interphalangeal joint stiffness. This cutting-edge design incorporates shape memory alloy into the device for improving proximal interphalangeal joint stiffness and, secondarily, enhancing the ability to perform activities.
Half of the participants will be assigned to experimental group, receiving a shape memory alloy-based orthosis for home program. The other half will be assigned to control group, receiving a conventional stretching program. Three evaluations, examining range of motion and hand functional performance, will be conducted before intervention, 4 weeks and 8 weeks after baseline by the researchers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-79 years old
- •Exhibit limitations in passive range of motion of the proximal interphalangeal joint, with extension less than 0 degrees or flexion less than 90 degrees.
- •Beyond the acute phase of the hand condition, and it has been more than 8 weeks post-surgery (or post-injury).
排除标准
- •Concurrently use other types of splints for PIP joint stiffness.
- •Present with abnormal muscle tone, paralysis, or rigidity associated with central or peripheral nervous system dysfunction.
- •Suffer from complex regional pain syndrome or progressive degenerative disease affecting finger joints, such as rheumatoid arthritis.
- •Have an active infection or arthritis in their fingers.
- •Unable to follow instructions.
研究组 & 干预措施
SMA group
Participants in the SMA group will use the shape memory alloy-based orthosis. They will undergo a 30-minute home-based training program 3-4 times a day, 7 days a week, for 8 weeks.
干预措施: shape memory alloy-based orthosis (Other)
Stretching group
Participants in the Stretching group will receive conventional stretching program as a home program. They will undergo a 30-minute home-based training program 3-4 times a day, 7 days a week, for 8 weeks.
干预措施: conventional stretching program (Other)
结局指标
主要结局
Range Of Motion
时间窗: Baseline, 4 weeks after baseline, and 8 weeks after baseline
Active, passive and torque range of motion are common measurements to assess joint mobility limitations in clinical settings. Active range of motion is measured as the maximum movement achieved by the patient's own efforts. Passive range of motion is measured when an external force, such as a therapist, moves the joint until the end feel is detected. Torque range of motion is assessed with a specific tension applied to the movement of interest. Normal proximal interphalangeal joint flexion range of motion typically ranges from 0-100 or 110 degrees.
次要结局
- Minnesota Manual Dexterity Test(Baseline, 4 weeks after baseline, and 8 weeks after baseline)
- Purdue Pegboard Test(Baseline, 4 weeks after baseline, and 8 weeks after baseline)
- Motion Capture and Analysis System(Baseline, 4 weeks after baseline, and 8 weeks after baseline)
- The Disability of the Arm, Shoulder and Hand Questionnaire, Taiwan version(Baseline, 4 weeks after baseline, and 8 weeks after baseline)
- System Usability Scale(8 weeks after baseline)