Efficacy of Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- PROMIS Physical Function CAT
研究概览
简要总结
Knee pain is one of the most prevalent musculoskeletal disorders in the United States. Conservative treatments generally consist of pharmacological agents and physical therapy. Unfortunately, such conservative care is often mismanaged, and little data is collected on clinical outcomes. The proposed investigation utilizes a novel and state-of-the-art mobile application (DETP) to guide an at-home exercise therapy program for non-operative knee pain. The purpose of this study is conducting a single-blind randomized, controlled, superiority study to compare the DETP to conventional physical therapy (PT). The investigators will seek to determine improvement in pain and function in PROMIS measures as the primary outcome. The investigators will also evaluate satisfaction with the application as a secondary outcome.
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 (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75, inclusive.
- •Diagnosis of knee injury. For participants enrolled from the Mayo healthcare system database, knee injury identified from electronic medical records.
- •Pain Numerical Rating Scale score of 4 or greater on a 0-10 scale (0 = no pain, 10 = pain).
- •Participants must be diagnosed with a knee injury and the next step of care is either a home exercise program or external physical therapy ordered at the academic center.
- •Prescribed external physical therapy (i.e., therapy not completed at Mayo Clinic in Rochester/Minneapolis).
排除标准
- •No access to android or iPhone smartphone
- •BMI greater than or equal to 35
- •Previously completed series of physical therapy visits for knee injury within the past 12 months for the same injury (received one introduction PT session as seen in executive program will not be considered an exclusion).
- •Recommended by a physician for consideration of total knee replacement.
- •Diagnosis of rheumatoid arthritis, fibromyalgia, gout in the knee, or other systemic rheumatic disease.
- •Hospitalization for a stroke, heart attack, heart failure, or had surgery for blocked arteries in the past 12 months.
- •Total joint replacement knee surgery, bucket-handle meniscus tear, ACL tear, or other knee surgery in the past 12 months.
- •Unable to speak English.
- •Active diagnosis of psychosis.
- •Fall history deemed by a physician to impose risk for potential injury with participation in a home-based exercise program.
- •Severely impaired hearing or speech.
结局指标
主要结局
PROMIS Physical Function CAT
时间窗: 8 weeks
Function is measured by 0-100. 0= no function and 100 = high function
PROMIS Pain Score
时间窗: 8 weeks
Pain is measured by 0-100. 0 = no pain and 100 = very high pain
次要结局
- Subject Satisfaction Questions(8 weeks)
研究者
Jacob L. Sellon, M.D.
Principal Investigator
Mayo Clinic