Randomized Controlled Trial for Post-operative Fracture Distal Radius Rehabilitation - The Early Motion Protocol Rehabilitation vs. Early Strengthening Study (EMPRESS Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Region-specific patient reported functional outcome score
研究概览
简要总结
The primary objective of this study is to demonstrate safety and efficacy of an early strengthening and passive mobilization rehabilitation program for post-operative distal radius fracture fixation surgery compared to current conventional rehabilitation.
详细描述
Functional outcome after distal radius fracture fixation has often been variable with multiple factors affecting final results. Early mobilization rehabilitation protocols have been the gold standard after fracture fixation surgery. Rehabilitation protocols vary from center to center's own practices. However, these commonly encompass an early mobilization protocol or otherwise known as accelerated rehabilitation or enhanced recovery after surgery (ERAS) programs. Such programs comprise of a short duration of immobilization followed by a period of active mobilization before strengthening exercises are employed.
The investigators have performed early motion protocol (EMP) rehabilitation in the last decade in the investigation center for post-operative fracture distal radius fixation patients. The early motion protocol allows immediate active mobilization without a period of immobilization or splint protection. Despite early mobilization rehabilitation, there are a subset of patients who develop significant stiffness and pain with poor functional outcomes, especially in the early post-operative period. Moreover, some patients may also develop complex regional pain syndrome (CRPS) albeit early active mobilization. Thus, an early strengthening protocol (ESP) was developed to allow for immediate strengthening and passive mobilization exercises post-operatively with physiotherapist and occupational therapist guidance. Herein this study, the investigators hope to demonstrate the safety and efficacy of an ESP rehabilitation compared to EMP for post-operative distal radius fracture fixation.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are randomly assigned to either one of the interventional arm and will not be informed of the randomisation result.
Surgeons and assessors are blinded to the intervention allocated.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50 years or older
- •Diagnosed with an isolated closed injury, displaced, distal radius fracture (AO/OTA Classification 23-A1-3, B1-2, C1-2) without articular comminution
- •Requires operative fixation
- •Able to give consent
排除标准
- •History of previous hand or wrist surgery
- •Neurological injury or pre-existing neurological conditions to the upper limb
- •Underlying osteoarthritis of the wrist
- •Unfit for surgical anesthesia
- •Subacute fractures with delayed presentation (>2 weeks since initial injury)
- •Unable to consent
- •Refuse surgical intervention
- •Unable to follow commands for rehabilitation
- •Fixation construct or injuries requiring immobilization after surgery, such as unfixed distal ulna head or shaft fractures that require splintage or distal radio-ulnar joint instability planned for immobilization
研究组 & 干预措施
Early Strengthening Protocol (ESP)
Early use of strength and passive stretching will be encouraged after their initial assessment by rehabilitation therapists within 2 weeks of their discharge.
干预措施: Early Strengthening Protocol (Other)
Early Motion Protocol (Control)
Active mobilization is continued for the initial post-operative 6 weeks with allied health therapists, while passive mobilization and strengthening are started at the post-operative 8-10-week period.
干预措施: Early Motion Protocol (Other)
结局指标
主要结局
Region-specific patient reported functional outcome score
时间窗: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Physical function and symptoms measured by Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH), an 11-item patient-reported measure with a total score ranging from 0 (no disability) to 100 (most severe disability).
Range of motion
时间窗: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Subjects' wrist range of motion, including: pronation, supination, flexion, and extension will be measured by allied health therapists at each follow-up timepoint.
Grip strength
时间窗: ESP group: At post-op weekly from 1 to 12 weeks, 6 months and 12 months ; EMP group: At post-op weekly from 6 to 12 weeks, 6 months and 12 months
Grip strength will be measured using a dynamometer weekly for the ESP group and weekly from 6 weeks onwards for the EMP group.
次要结局
- Health-related Quality of Life Measured by SF-12 Chinese (HK) Version(At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months)
- Radiographic outcomes(At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months)
- Incidence of complications(At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months)
- Qualitative self-reported compliance(At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months)
研究者
Prof. Christian Xinshuo Fang
Clinical Associate Professor
The University of Hong Kong