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Telerehabilitation After Shoulder Arthroplasty

Primary Purpose

Arthritis Shoulder Glenohumoral Joint, Rotator Cuff Tear Arthropathy, Arthropathy Shoulder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telerehabilitation; physical therapy via telecommunication device (i.e. online video conferencing)
Sponsored by
Olivia C. O'Reilly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis Shoulder Glenohumoral Joint focused on measuring Shoulder arthroplasty, Physical therapy, Telerehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Brendan Patterson

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telerehabilitation

Traditional In-Person Physical Therapy

Arm Description

Subjects who are randomized to telerehabilitation will be provided access to telemedicine visits with a physical therapist. Patients will have one in-person physical therapy visit before starting telerehabilitation, and another in-person visit at 3 months to assess progress. Telerehabilitation visits will be performed via secure usage of the electronic medical record (EMR). 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.

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.

Outcomes

Primary Outcome Measures

Shoulder range of motion
Patient's ability to actively and passively move the shoulder in multiple planes of motion
American Shoulder and Elbow Surgeons score
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.
PROMIS Pain Interference
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.
PROMIS Global Health score
A patient reported outcome measure detailing self-reported markers of overall patient health. A higher score represents a healthier patient in that specific domain.
Visual Analog Scale for Pain
A patient reported outcome measure detailing pain intensity using a numerical value from 1-10. A higher score indicates worse pain.

Secondary Outcome Measures

Full Information

First Posted
July 15, 2022
Last Updated
October 24, 2023
Sponsor
Olivia C. O'Reilly
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1. Study Identification

Unique Protocol Identification Number
NCT05499728
Brief Title
Telerehabilitation After Shoulder Arthroplasty
Official Title
Physical Therapy Following Shoulder Arthroplasty: An Assessment of Telerehabilitation vs. In-Person Physical Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olivia C. O'Reilly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis Shoulder Glenohumoral Joint, Rotator Cuff Tear Arthropathy, Arthropathy Shoulder
Keywords
Shoulder arthroplasty, Physical therapy, Telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
Subjects who are randomized to telerehabilitation will be provided access to telemedicine visits with a physical therapist. Patients will have one in-person physical therapy visit before starting telerehabilitation, and another in-person visit at 3 months to assess progress. Telerehabilitation visits will be performed via secure usage of the electronic medical record (EMR). 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.
Arm Title
Traditional In-Person Physical Therapy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation; physical therapy via telecommunication device (i.e. online video conferencing)
Intervention Description
Postoperative physical therapy performed through online video conferencing with a licensed physical therapist while the patient remains remote/at home rather than in person
Primary Outcome Measure Information:
Title
Shoulder range of motion
Description
Patient's ability to actively and passively move the shoulder in multiple planes of motion
Time Frame
2 years
Title
American Shoulder and Elbow Surgeons score
Description
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.
Time Frame
2 years
Title
PROMIS Pain Interference
Description
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.
Time Frame
2 years
Title
PROMIS Global Health score
Description
A patient reported outcome measure detailing self-reported markers of overall patient health. A higher score represents a healthier patient in that specific domain.
Time Frame
2 years
Title
Visual Analog Scale for Pain
Description
A patient reported outcome measure detailing pain intensity using a numerical value from 1-10. A higher score indicates worse pain.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients being indicated for primary shoulder arthroplasty, both anatomic and reverse shoulder arthroplasty, by one of two orthopedic shoulder surgeons. Exclusion Criteria: Patients undergoing revision procedures, concomitant procedures (for example, tendon transfer), arthroplasty for fracture, and those who do not wish to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivia O'Reilly, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brendan M Patterson, MD, MPH
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brendan Patterson
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29658976
Citation
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Results Reference
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Citation
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Results Reference
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31356423
Citation
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Results Reference
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31021690
Citation
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Results Reference
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Citation
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Citation
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Citation
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Telerehabilitation After Shoulder Arthroplasty

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