Using a Mobile Application for In-Bed Conditioning Exercises for Orthopedic Postoperative Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in patient performance during physical therapy (PT)
研究概览
简要总结
This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery.
详细描述
The study aims to assess the effectiveness of a mobile app-based tool in improving conditioning, mobility, and physical therapy performance among patients recovering from orthopedic surgery, particularly hip fracture fixation, spinal fusion, and total knee/hip arthroplasty. The app sets reminders for in-bed conditioning exercises, with difficulty levels adjusted based on patient feedback. The prospective, single-arm pilot study will enroll patients over 65 years old with adequate cognitive status and a mobile phone. Patient performance on the app, satisfaction metrics, and physical therapy outcomes will be evaluated, along with feedback from physical therapists. The study is conducted through the Yale New Haven Health System, with plans to enroll 15 patients initially and subsequently expand to a randomized controlled trial with 50 participants in each arm. The goal is to improve outcomes in this population, characterized by poor mobility, morbidity, and mortality rates, by supplementing inpatient rehabilitation with targeted, app-prompted exercises.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •English reading/speaking
- •Are status post low-energy hip fracture, total knee/hip arthroplasty, or single to multilevel spinal fusion without paralysis
- •Must be able bodied enough to participate in a mobile app tool for physical therapy
- •Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration]
排除标准
- •Severe cognitive impairment: Not alert and oriented to person, place, time, and reason for being the hospital; and unable to follow 2 step commands
- •Severe physical impairment:
- •Neurologic paralysis
- •Polytraumas with restrictions incompatible with anti-gravity exercises
- •Knee immobilization, bed rest
- •Unstable medical conditions:
- •On ventilatory support
- •Utilizing high degrees of oxygen support (continuous BiPAP, high flow nasal cannula, nonrebreather mask, aerosol mask >3L/min)
- •Hemodynamic instability requiring pressor medication support (can include those on pressors for elevated mean arterial pressure goals (MAPs))
- •Neurologically instable with strokes, hemorrhages, increased intracranial pressures
- •Open wounds or surgical incisions
- •Tenuous closed wounds requiring immobilization or bending restrictions
- •Open wounds that are either packed/dressed or dressed with a wound vacuum
- •Surgical wounds that are draining fluid or purulence
- •Vulnerable populations
- •Incarcerated individuals
- •Patients without access to a mobile phone with iOS capability
研究组 & 干预措施
Enhanced Care
Post-operative usual care where patients will receive standard care plus the use of a tool.
干预措施: App for in-bed conditioning exercises (Device)
Enhanced Care
Post-operative usual care where patients will receive standard care plus the use of a tool.
干预措施: Usual care (Other)
Usual Care
Post-operative usual care where patients will receive standard care alone.
干预措施: Usual care (Other)
结局指标
主要结局
Change in patient performance during physical therapy (PT)
时间窗: Initial (postoperative day 1) and Final PT Visit (at discharge approximately day 3-5 postoperative)
Patient performance during physical therapy will be assessed using The Activity Measure for Post-Acute Care (AMPAC). The AMPAC score is a comprehensive assessment tool used to evaluate a patient's functional abilities in various domains, including mobility, daily activities, and social interaction. Total score range from 6-24 with higher scores indicating the participant is able to independently perform all activities.
次要结局
- Patient-reported satisfaction metrics(at postoperative day 3-5)
- Postoperative VAS scores(immediately postoperative and day of last admission, up to 5 days)
- Patient performance on the app(an average of 3-5 days)
- Patient compliance with prescribed exercises(an average of 3-5 days)
- Physical therapist feedback on app setup assistance, patient interaction, and suggestions for improvement to assess feasibility(up to 120 days)
- Length of stay(an average of 3-5 days)
- Adverse Events(Up to 90 Days)