Telerehabilitation Following Ankle Fractures: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in self-reported function
研究概览
简要总结
Background and Purpose: Ankle fractures represent one of the most common fractures in North America. Surgical fixation is often required in the presence of dislocation or instability and has been shown to have a high rate of success. Following surgical fixation, physical therapy is commonly utilized to assist in regaining function. Advice alone has been shown to be non-inferior to traditional physical therapy for patients post-ankle fracture in two studies. The results of these studies have yet to be repeated in the US. It is the intent of this study to investigate the feasibility of a large clinical trial comparing the results of traditional physical therapy and an internet-based telerehabilitation program. Following surgical repair of ankle fractures, patients will be randomized to traditional rehabilitation or telerehabilitation. Telerehabilitation may represent an alternative patient option to traditional physical therapy following ankle fracture repair. The results of this study will inform the design of larger multi-site clinical trials investigating the effectiveness of telerehabilitation for this patient population.
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
- •Bimalleolar or trimalleolar fracture
- •Repaired with open reduction internal fixation technique
- •Must have access to computer, tablet, or smart phone with internet access
排除标准
- •Severe soft tissue damage associated with injury
- •Physical or mental conditions that will affect patient's ability to participate in independent rehabilitation
- •Non-English speaking
研究组 & 干预措施
Traditional Physical Therapy
Patients will be given a prescription to see a physical therapist and a paper-based rehabilitation protocol. Patients will be allowed to receive physical therapy at a location of patients' choosing. This arm represents the current standard of care.
干预措施: Standard rehabilitation (Other)
Telerehabilitation
Patients will be given access to a website containing instructions with pictures and videos for the exercises patients are to complete as part of patients' rehabilitation. Patients will not be given a prescription to physical therapy. Patients in this group will receive weekly calls from a physical therapist during weeks 6-12 post-operatively.
干预措施: Telerehabilitation (Other)
结局指标
主要结局
Change in self-reported function
时间窗: At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
Measured by the Lower Extremity Functional Scale, a patient-reported function of the lower extremity. Scores range from 0-80 with lower scores indicating increased impairment levels.
次要结局
- Out of pocket cost(6 months)
- Self-Efficacy for Home Exercise Program as assessed by a 12-Item questionnaire(2 weeks)
- Travel time (hours)(6 months)
- Change in self-reported quality of life(At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months)
- Change in pain as assessed by the Brief Pain Inventory short form(At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months)
- Patient Satisfaction as assessed by a 0-10 satisfaction scale(6 months)
- Fear of pain with movement as assessed by the Tampa Kinesiophobia Scale(2 weeks)