Evaluation of the Efficacy of an Early Rehabilitation Intervention, Supported by Telemedicine, Compared to the Usual Rehabilitation Intervention, in Patients With Distal Radius Fracture. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of Patient Related Wrist Evaluation score from Day 28 at Day 56 post ranndomization
研究概览
简要总结
This is a randomized clinical trial of two parallel arms, aiming to compare two rehabilitation interventions: an experimental intervention including telemedicine support and remote monitoring of compliance of usual indicated exercises, versus the usual protocol of indicated exercises supported by printed material (triptych) and without remote monitoring
详细描述
Distal radius fracture is a common pathology. The surgical indication is given by the difficulty in obtaining fracture reduction or by the instability of the fracture. The long-term functional prognosis of the wrist depends largely on patients' adherence to the prescribed indications/exercises in the immediate postoperative phase.
This is a randomized clinical trial of two parallel arms, aiming to compare two rehabilitation interventions: an experimental intervention including telemedicine support and remote monitoring of compliance of usual indicated exercises, versus the usual protocol of indicated exercises supported by printed material (triptych) and without remote monitoring.
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)
盲法说明
The outcomes assessor is a physical therapist independent of the research team, who is blind to the treatment assignment
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
- •distal radial fracture (A2 to C3 type according to the Orthopaedic Trauma Association classification system)
- •indication for standard rehabilitation post-surgery
排除标准
- •immediate post-surgery complication
- •multiple fractures or severe injuries
- •history of bone metabolism condition
- •illiterate
- •non-Spanish speaking
- •mental disorder
- •not familiar with electronic devices
结局指标
主要结局
Change of Patient Related Wrist Evaluation score from Day 28 at Day 56 post ranndomization
时间窗: Day 56
Patient Related Wrist Evaluation is a 15-item validated scale, range from 0 to 100, where higher scores are worse outcomes
Adherence to prescribed excercise program
时间窗: Day 56
The digital pad will objectively register adherence to exercises; the control group will self-report their compliance rates with the prescribed exercises
次要结局
- Wrist flexion and extension(Day 28; Day 56)
- Grip strength(Day 28; Day 56)
研究者
Felipe Andrés Correa Salazar
Physical therapist
Hospital Clinico Mutual de Seguridad