Recruiting

Prehabilitation

Sponsor:

University of Florida

Code:

NCT07145957

Conditions

Primary Reverse Total Shoulder Arthroplasty

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Prehabilitation

Study Details

Brief summary:

Difficulty with internal rotation (IR) after reverse shoulder arthroplasty (RSA) is common. Current rehabilitation protocols may not optimize IR. The investigator's objective is to assess the impact of prehabilitation focused on IR strengthening and mobility on RSA outcomes. The investigators will perform a prospective, randomized control trial to achieve the specific aim: assessing range of motion, strength, patient-reported outcomes, and activities of daily living requiring internal rotation between control and prehabilitation cohorts, with the prehabilitation patients receiving 6 weeks of treatment.

Conditions

Primary Reverse Total Shoulder Arthroplasty

Study ID

NCT07145957

Start date

Nov 6, 2025

Status verified date

Jan, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria: • Patients aged 40-80

  • Undergoing primary RSA for glenohumeral osteoarthritis or rotator cuff arthropathy
  • Must be able to read and speak English
  • Willing and able to attend a monthly therapy session and perform exercises at home for a minimum of 6 weeks before surgery
  • Willing and able to participate in postoperative monitoring for a minimum of 2 years

Exclusion Criteria:

  • Patients under the age of 40 and over the age of 80.
  • Diagnosis of septic shoulder, fracture, or fracture sequelae, or tumor pathology of the ipsilateral shoulder
  • Pre-existing hand, wrist, or elbow pathology that limits elbow flexion or extension, or forearm pronation or supination
  • Planned to undergo synchronous procedure of the involved extremity (e.g., synchronous RSA and carpal tunnel release)
  • Tendon transfer (e.g., Latissimus dorsi transfer) performed intraoperatively
  • Patients without access to phone or email communication for at least 2 years after treatment
  • Revision shoulder arthroplasty

Study Design

Enrollment

64 participants

Anticipated

Interventions and Outcome Measures

Arms

treatment (IRTx)

IRTx group to complete the preoperative rehabilitation program

control (COS)

Interventions

Prehabilitation

subjects randomized to the IRTx cohort will also be instructed by a Physical or Occupational Therapist to perform the exercises described in the RSA IR Prehab Exercise Protocol handout, 5-7 times per week for 6 weeks.

Primary outcome measure

  • Activities of Daily Living which require Internal Rotation (ADLIR) questionnaire [ Time Frame: 6-8 Weeks pre surgery, 2 Weeks pre surgery, and 12 weeks, 6 months, 1 year, 2 years post surgery ]

Central Contacts and Locations

Central contacts

Jonathan Wright, MD

(352) 273-7374wrightjo@ortho.ufl.edu

Aimee Struk, MEd

(352) 273-7419strukam@ortho.ufl.edu

Locations

University of Florida Department of Orthopaedics and Rehabilitation

Recruiting

Gainesville, Florida, United States, 32607

Contacts

Jonathan Wright, MD

352-273-7374wrightjo@ortho.ufl.edu

Aimee Struk, MEd

352-273-7419strukam@ortho.ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-01-14.