Telerehabilitation for Shoulder Surgery Recovery: A Randomized Trial Assessing the Effectiveness of the Band Connect Platform
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in American Shoulder and Elbow Surgeons (ASES)
研究概览
简要总结
This study aims to evaluate the effectiveness of a telerehabilitation protocol utilizing the Band Connect platform in patient recovery following rotator cuff repair surgery. This will be a randomized control trial with patients assigned into a traditional rehabilitation or a telerehabilitation protocol.
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
- None
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
- •Adults aged 18 years or older
- •Scheduled for primary arthroscopic rotator cuff repair Surgery to be performed by Dr. Young Kwon, Dr. Mandeep Virk, Dr. Dennis DeBernardis, or Dr. Jie Yao
- •Planning to complete postoperative physical therapy at selected NYU physical therapy locations
- •Access to home internet and a wireless cell phone compatible with the Band Connect App
排除标准
- •Patients undergoing revision RCR
- •Patients whose post operative rehabilitation has to be delayed or modified.
- •Pregnant individuals
- •Shoulder injuries related to workers compensation or involved in any pending litigation
- •Patients unable to provide informed consent
研究组 & 干预措施
Control
Individuals in the control arm will complete standard physical therapy sessions.
干预措施: Physical Therapy (Behavioral)
Band Connect Intervention
Individuals in the experimental arm will complete standard physical therapy sessions while using the Band Connect device, which allows for direct measurement of patient force generated as well as positioning during the completion of physical therapy exercises.
干预措施: Physical Therapy (Behavioral)
Band Connect Intervention
Individuals in the experimental arm will complete standard physical therapy sessions while using the Band Connect device, which allows for direct measurement of patient force generated as well as positioning during the completion of physical therapy exercises.
干预措施: Band Connect (Device)
结局指标
主要结局
Change in American Shoulder and Elbow Surgeons (ASES)
时间窗: Baseline, Month 6
The ASES is a 17-item questionnaire measuring shoulder pain and function. The total score is standardized into a 0-100 scale; higher scores indicate less pain/greater function.
次要结局
- Change in Visual Analogue Scale (VAS) Pain Score(Baseline, Month 6)
- Change in PROMIS Upper Extremity - Short Form 7a Score(Baseline, Month 6)
- Change in Days Per Week of Physical Therapy(Baseline, Month 6)
- Change in Intensity of Physical Therapy(Baseline, Month 6)