Telerehabilitation After Shoulder Arthroplasty

NCT05499728 | Completed

• 1 other identifier: 202104097
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Shoulder arthroplasty; Physical therapy; Telerehabilitation

Outcome Measures

Primary Outcomes (5)

• Shoulder range of motion

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

  2 years

• 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.

  2 years

• 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.

  2 years

• 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.

  2 years

• 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.

  2 years

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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.

Other: Telerehabilitation; physical therapy via telecommunication device (i.e. online video conferencing)

Traditional In-Person Physical Therapy

NO INTERVENTION

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.

Interventions

Telerehabilitation; physical therapy via telecommunication device (i.e. online video conferencing) OTHER

Postoperative physical therapy performed through online video conferencing with a licensed physical therapist while the patient remains remote/at home rather than in person

Telerehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

Brendan Patterson

Iowa City, Iowa, 52242, United States

Location

Related Publications (14)

• Palsis JA, Simpson KN, Matthews JH, Traven S, Eichinger JK, Friedman RJ. Current Trends in the Use of Shoulder Arthroplasty in the United States. Orthopedics. 2018 May 1;41(3):e416-e423. doi: 10.3928/01477447-20180409-05. Epub 2018 Apr 16.

  PMID: 29658976 BACKGROUND

• Chalmers PN, Salazar DH, Romeo AA, Keener JD, Yamaguchi K, Chamberlain AM. Comparative Utilization of Reverse and Anatomic Total Shoulder Arthroplasty: A Comprehensive Analysis of a High-volume Center. J Am Acad Orthop Surg. 2018 Dec 15;26(24):e504-e510. doi: 10.5435/JAAOS-D-17-00075.

  PMID: 30161057 BACKGROUND

• Wright MA, Keener JD, Chamberlain AM. Comparison of Clinical Outcomes After Anatomic Total Shoulder Arthroplasty and Reverse Shoulder Arthroplasty in Patients 70 Years and Older With Glenohumeral Osteoarthritis and an Intact Rotator Cuff. J Am Acad Orthop Surg. 2020 Mar 1;28(5):e222-e229. doi: 10.5435/JAAOS-D-19-00166.

  PMID: 31356423 BACKGROUND

• Bullock GS, Garrigues GE, Ledbetter L, Kennedy J. A Systematic Review of Proposed Rehabilitation Guidelines Following Anatomic and Reverse Shoulder Arthroplasty. J Orthop Sports Phys Ther. 2019 May;49(5):337-346. doi: 10.2519/jospt.2019.8616. Epub 2019 Apr 25.

  PMID: 31021690 BACKGROUND

• Mulieri PJ, Holcomb JO, Dunning P, Pliner M, Bogle RK, Pupello D, Frankle MA. Is a formal physical therapy program necessary after total shoulder arthroplasty for osteoarthritis? J Shoulder Elbow Surg. 2010 Jun;19(4):570-9. doi: 10.1016/j.jse.2009.07.012. Epub 2009 Oct 2.

  PMID: 19800258 BACKGROUND

• Keener JD, Galatz LM, Stobbs-Cucchi G, Patton R, Yamaguchi K. Rehabilitation following arthroscopic rotator cuff repair: a prospective randomized trial of immobilization compared with early motion. J Bone Joint Surg Am. 2014 Jan 1;96(1):11-9. doi: 10.2106/JBJS.M.00034.

  PMID: 24382719 BACKGROUND

• Boudreau S, Boudreau ED, Higgins LD, Wilcox RB 3rd. Rehabilitation following reverse total shoulder arthroplasty. J Orthop Sports Phys Ther. 2007 Dec;37(12):734-43. doi: 10.2519/jospt.2007.2562. Epub 2007 Aug 28.

  PMID: 18560182 BACKGROUND

• Uschok S, Herrmann S, Pauly S, Perka C, Greiner S. Reverse shoulder arthroplasty: the role of physical therapy on the clinical outcome in the mid-term to long-term follow-up. Arch Orthop Trauma Surg. 2018 Dec;138(12):1647-1652. doi: 10.1007/s00402-018-3015-9. Epub 2018 Jul 30.

  PMID: 30062455 BACKGROUND

• Romano AM, Oliva F, Nastrucci G, Casillo P, Di Giunta A, Susanna M, Ascione F. Reverse shoulder arthroplasty patient personalized rehabilitation protocol. Preliminary results according to prognostic groups. Muscles Ligaments Tendons J. 2017 Sep 18;7(2):263-270. doi: 10.11138/mltj/2017.7.2.263. eCollection 2017 Apr-Jun.

  PMID: 29264337 BACKGROUND

• Wolff AL, Rosenzweig L. Anatomical and biomechanical framework for shoulder arthroplasty rehabilitation. J Hand Ther. 2017 Apr-Jun;30(2):167-174. doi: 10.1016/j.jht.2017.05.009.

  PMID: 28641735 BACKGROUND

• Simovitch R, Flurin PH, Wright T, Zuckerman JD, Roche CP. Quantifying success after total shoulder arthroplasty: the minimal clinically important difference. J Shoulder Elbow Surg. 2018 Feb;27(2):298-305. doi: 10.1016/j.jse.2017.09.013. Epub 2017 Nov 20.

  PMID: 29162305 BACKGROUND

• Wagner ER, Solberg MJ, Higgins LD. The Utilization of Formal Physical Therapy After Shoulder Arthroplasty. J Orthop Sports Phys Ther. 2018 Nov;48(11):856-863. doi: 10.2519/jospt.2018.8176. Epub 2018 May 8.

  PMID: 29739303 BACKGROUND

• Palm KB, Blazar PE, Manna JC, Serig AS, Phillips EA, Bay CP, Casey EJ, Earp BE. Feasibility, effectiveness and patient satisfaction of telerehabilitation after thumb carpometacarpal arthroplasty and reverse total shoulder arthroplasty: A pilot study. J Telemed Telecare. 2023 Aug;29(7):521-529. doi: 10.1177/1357633X21999578. Epub 2021 Mar 5.

  PMID: 33673751 BACKGROUND

• Pastora-Bernal JM, Martin-Valero R, Baron-Lopez FJ, Estebanez-Perez MJ. Evidence of Benefit of Telerehabitation After Orthopedic Surgery: A Systematic Review. J Med Internet Res. 2017 Apr 28;19(4):e142. doi: 10.2196/jmir.6836.

  PMID: 28455277 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Olivia O'Reilly, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Brendan M Patterson, MD, MPH

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: August 12, 2022
• Study Start: August 18, 2021
• Primary Completion: May 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)