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App-Based vs Office-Based Physical Therapy for Shoulder Surgery

N/A

Waitlist Available

Led By Tyler J Brolin, MD

Research Sponsored by Campbell Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares home-based rehabilitation with an app to office-based physical therapy after shoulder surgery. Researchers want to see if outcomes are the same.

Who is the study for?

This trial is for adults over 18 who've had a primary reverse shoulder replacement due to specific conditions like cuff tear arthropathy, massive rotator cuff tears, osteoarthritis, or inflammatory arthritis. Participants must have a compatible smartphone for the mymobility app. It's not for those with additional tendon procedures, previous shoulder replacements, under 18s, or if they need inpatient rehab post-surgery.

What is being tested?

The study is testing whether using the Zimmer Biomet mymobility app for self-directed physical therapy after shoulder replacement surgery gives the same recovery results as standard office-based physical therapy sessions.

What are the potential side effects?

Since this trial involves non-invasive digital and standard physical therapies rather than medication or surgical interventions, significant side effects are not anticipated. However, participants may experience typical discomfort associated with any physical rehabilitation process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: mymobility Physical TherapyExperimental Treatment1 Intervention

The mymobility Physical Therapy cohort will complete an identical protocol to the Standard Office-based Physical Therapy cohort with one exception: the mymobility cohort's therapy for the entire duration of the protocol is administered at home through the mymobility application. This cohort initiates use of the mymobilty application one postoperative day 1. Exercises and restrictions are described in-depth in the Study Protocol document.

Group II: Standard Office-based Physical TherapyActive Control1 Intervention

The Standard Office-based Physical Therapy cohort completes an identical protocol to the mymobility Physical Therapy cohort with one exception: rather than through use of the mymobility application, the Standard Office-based Physical Therapy cohort's protocol is administered through the traditional means of an exercise handout for postoperative day 1 through 2 weeks followed by formal office-based physical therapy for the duration of the protocol. Exercises and restrictions are described in-depth in the Study Protocol document.

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