Does Undergoing a Prehabilitation Protocol Aimed at Optimizing Scapulothoracic Mobility and Strengthening Improve Internal Rotation After Reverse Shoulder Arthroplasty?

NCT07145957 | Recruiting

• 1 other identifier: IRB202501188
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Activities of Daily Living which require Internal Rotation (ADLIR) questionnaire

  Activities of Daily Living questionnaire with a scale of 9 = worst, 100 = best Shoulder Internal Range of Motion Measurements with scoring scale: 0 = Thigh or less.1 = Hip. 2 = Buttocks, 3 =Sacrum, 4 = L4-L5, 5 = L1-L3, 6 = T12-T8, 7 = T7 or Higher

  6-8 Weeks pre surgery, 2 Weeks pre surgery, and 12 weeks, 6 months, 1 year, 2 years post surgery

Secondary Outcomes (1)

• Shoulder Internal Range of Motion Measurements

  6-8 Weeks pre surgery, 2 Weeks pre surgery, and 12 weeks, 6 months, 1 year, 2 years post surgery

Study Arms (2)

treatment (IRTx)

IRTx group to complete the preoperative rehabilitation program

Other: Prehabilitation

control (COS)

Interventions

Prehabilitation OTHER

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.

treatment (IRTx)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those patients who are indicated for primary reverse total shoulder arthroplasty with one of the attending surgeons on the study team that meet the inclusion/exclusion criteria will be approached by study team members to provide informed consent.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• American Shoulder and Elbow Surgeons: collaborator

Study Sites (1)

University of Florida Department of Orthopaedics and Rehabilitation

Gainesville, Florida, 32607, United States

RECRUITING

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jonathan Wright, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Wright, MD

CONTACT

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

Aimee Struk, MEd

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)