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临床试验/NCT05499728
NCT05499728已完成不适用

Physical Therapy Following Shoulder Arthroplasty: An Assessment of Telerehabilitation vs. In-Person Physical Therapy

University of Iowa1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2021年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
1
主要终点
Shoulder range of motion

研究概览

简要总结

The use of reverse total shoulder arthroplasty (RSA) has increased dramatically in the United States in recent years. The importance of postoperative physical therapy in the setting of anatomic total shoulder is well understood and explored in the literature. The literature describing postoperative physical therapy for RSA, however, is scarce and somewhat limited to the field of physiatry in the form of clinical commentary on rehabilitation programs.In addition, the use of formal in-person therapy versus physician-guided home therapy has been explored in total shoulder arthroplasty, demonstrating similar post-operative range of motion and patient-reported outcome (PROs) between groups. Furthermore, previous research into "telerehabilitation" or remote physical therapy through a video-based platform has demonstrated noninferiority in outcomes in multiple orthopedic procedures, including hip and knee arthroplasty and reverse shoulder arthroplasty. Telehealth therapy has not yet been formally evaluated in a randomized approach for reverse or anatomic total shoulder arthroplasty. Given the ongoing COVID-19 pandemic, emphasis on social distancing, and multiple states having issued "stay at home" orders, a study into the effectiveness of telerehabilitation on current postoperative outcomes in shoulder arthroplasty may influence postoperative management and allow patients an alternative route for rehabilitation that allows more flexibility in completing, as well as limits potentially extraneous travel and exposure. The project will be a randomized control trial evaluating formal in-person physical therapy versus telerehabilitation after shoulder arthroplasty. Patients who undergo shoulder arthroplasty will complete either formal physical therapy or telerehabilitation postoperatively. The aim will be to identify any differences in shoulder range of motion, pain, or patient-reported outcome measures (PROs) between those who complete in-person physical therapy versus telerehabilitation therapy.

详细描述

After agreeing to participate and signing the informed consent, subjects will be randomized into in person physical therapy group or telerehabilitation group. At the 2-week postoperative visit, the subject will receive a sealed envelope which will contain the information about the group they have randomly been assigned to. Both groups (in person therapy and telerehabilitation) are expected to start physical therapy at 6-week after surgery, this means that all subjects will have 4 weeks after being assigned to program and organize for physical therapy.

Subjects who are randomized to in-person therapy will present to a physical therapist of their choice with a established written protocol. The therapy protocol is developed in conjunction with the Department of Orthopaedic Surgery and the Department of Physical Therapy. Subjects are recommended to attend in-person appointments at least once a week as well as perform home exercises. Progress with therapy will be collected with weekly phone calls from the research team. It is expected most subjects will complete formal physical therapy by 6 months postoperative attending on average 5-6 visits, measured by the time at which patient's regain functional range of motion or are instructed by their therapist to discontinue. Shoulder range of motion will be measured with a goniometer preoperatively, as well as 3,6, 12, and 24 months postoperatively at their regularly scheduled clinic visit. (Shoulder arthroplasty patients regularly return to clinic at these intervals and would not be required to present to clinic in addition to these time points. Patients also regularly return to clinic at 2 weeks and 6 weeks postoperatively as a part of their normal clinical follow up for wound check and general assessment.) Subjects who are randomized to telerehabilitation will be provided access to telemedicine visits with a physical therapist. These patients will have one first in-person physical therapy visit before starting telerehabilitation, and another in-person physical therapy visit at 3 months to assess progress. Telerehabilitation visits will be performed via secure usage of the electronic medical record (EMR). Progress with telerehabilitation will be collected with weekly phone calls from the research team. To ensure uniformity, and to allow for appropriate access to telehealth services, all telehealth visits will be carried out through the study institution's Department of Physical Therapy. It is expected most patients will complete formal physical therapy by 6 months postoperative measured by the time at which patient's regain functional range of motion or patients are satisfied with their results. Shoulder range of motion will be measured with a goniometer preoperatively, as well as 3,6, 12, and 24 months postoperatively at their regularly scheduled clinic visit. (Shoulder arthroplasty patients regularly return to clinic at these intervals and would not be required to present to clinic in addition to these time points. Patients also regularly return to clinic at 2 weeks and 6 weeks postoperatively as a part of their normal clinical follow up for wound check and general assessment.)

Review of the medical record will collect the following demographic information: medical record number, surgical date, age, BMI, smoking status, rheumatoid arthritis diagnosis, rotator cuff arthropathy diagnosis, subscapularis repair description, intraoperative integrity of the rotator cuff, physical therapy modality (in-person vs. telerehabilitation), physical therapy progress notes, and therapy compliance. Outcome measures will include shoulder range of motion including forward flexion, internal and external rotation, and all patient-reported outcome measures (PROs) assigned to shoulder arthroplasty patients already available for collection in Epic.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients being indicated for primary shoulder arthroplasty, both anatomic and reverse shoulder arthroplasty, by one of two orthopedic shoulder surgeons.

排除标准

  • Patients undergoing revision procedures, concomitant procedures (for example, tendon transfer), arthroplasty for fracture, and those who do not wish to participate

结局指标

主要结局

Shoulder range of motion

时间窗: 2 years

Patient's ability to actively and passively move the shoulder in multiple planes of motion

PROMIS Pain Interference

时间窗: 2 years

A patient reported outcome measure detailing self-reported consequences of pain and the extent to which, over a immediate 7-day recall period, pain influences patient well-being and activity. A higher score indicates a higher degree of pain interference.

American Shoulder and Elbow Surgeons score

时间窗: 2 years

A patient reported outcome measure utilizing a 100-point scale that assesses pain (50 points) and activities of daily living (50 points). A higher score (100) indicates a better shoulder condition.

Visual Analog Scale for Pain

时间窗: 2 years

A patient reported outcome measure detailing pain intensity using a numerical value from 1-10. A higher score indicates worse pain.

PROMIS Global Health score

时间窗: 2 years

A patient reported outcome measure detailing self-reported markers of overall patient health. A higher score represents a healthier patient in that specific domain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brendan M. Patterson

Physician

University of Iowa

研究点 (1)

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