A Randomized Controlled Trial Comparing Traditional Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture: a Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Patient-Rated Wrist Evaluation (PRWE)
研究概览
简要总结
Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture.
Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation.
Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE).
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
- None
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 radius fracture, which applies the surgical requirements
- •age between 18 to 65 years
- •Non concomitant injuries including ligament injuries and distal ulna fractures, however ulnar styloid avulsion is accepted
- •No significant comorbidities
- •No previous problems with the examined hand
- •Ability to understand Finnish fluently
排除标准
- •High energy or multiple injuries
- •Open fractures
- •Injury of both upper extremities
- •Other operative injury on the same side
- •Rheumatoid arthritis of other inflammatory joint disease
- •Heavy smoker (over 20 cigarettes per day)
- •Disease of medication slowing ossification
- •Alcohol or drug abuse
- •Psychiatric disorder with poor treatment balance
- •Neurological disorder which affects the function of the injured extremity
- •Fixation material other than a volar locking plate
- •Fracture fixation is not stable enough to start rehabilitation after 14 days
结局指标
主要结局
Patient-Rated Wrist Evaluation (PRWE)
时间窗: 12 months
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
次要结局
- Cost-utility analysis(12 months)
- Grip strength(12 months)
- Quick Disabilities of the arm, shoulder, and hand(12 months)
- Pain (Visual Analogue Scale)(12 months)
- Wrist range of motion (ROM)(12 months)
- Adverse events(12 months)
- Global improvement(12 months)
- Patient-rated Quality of Life (EQ-5D)(12 months)
研究者
Samuli Aspinen
Principal investigator
Hospital District of Helsinki and Uusimaa