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

Enrolling by invitation at 6 trial locations

Overseen By Margaret Knack, BSN, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Campbell Clinic

Disqualifiers: Revision surgery, Tendon transfer, Inpatient rehab, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods of physical therapy after shoulder surgery. One group will use an app called mymobility to guide their exercises at home, while the other group will attend a clinic for therapy. Researchers aim to determine if both methods yield similar results. This trial targets individuals who have undergone a specific type of shoulder replacement due to severe rotator cuff tears or arthritis and possess a compatible smartphone for the app.

As an unphased trial, this study allows participants to contribute to innovative research that could enhance recovery options for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this app-based physical therapy is safe for shoulder surgery rehabilitation?

Research has shown that app-based physical therapy, such as the mymobility platform, is generally safe for individuals recovering from shoulder surgery. A review found that telerehabilitation is as safe as in-person therapy, with no major safety differences between the two methods. However, specific safety details for the mymobility app itself are not provided in the sources. The widespread use of mymobility in many medical settings suggests it is well-accepted. Always consult your healthcare provider to determine if this option is suitable for you. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing mymobility Physical Therapy to standard office-based physical therapy because it explores a more flexible and accessible way to recover from shoulder surgery. Unlike traditional methods that require in-person visits and printed exercise handouts, mymobility uses a mobile application to guide patients through their entire rehabilitation process at home. This app-based approach could make it easier for patients to stick to their therapy routine, potentially improving recovery outcomes and offering greater convenience. By leveraging technology, mymobility has the potential to transform how physical therapy is delivered, making it more personalized and adaptable to individual patient needs.

What evidence suggests that this trial's treatments could be effective for shoulder surgery rehabilitation?

Research has shown that the mymobility digital platform, available to participants in this trial, can aid recovery after shoulder surgery. One study found that 97% of patients were satisfied using a mobile app for physical therapy, suggesting the app effectively guides home exercises. The trial also includes a group receiving Standard Office-based Physical Therapy, following a traditional in-office protocol. Evidence from similar surgeries, such as knee replacements, supports mymobility's success in aiding patient recovery. Overall, the platform offers a convenient and promising alternative to traditional in-office physical therapy. ^{1 4 6 7 8}

Who Is on the Research Team?

Tyler J Brolin, MD

Principal Investigator

Campbell Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Have a functioning smartphone model compatible with the mymobility platform

I had shoulder replacement surgery for specific shoulder issues.

Exclusion Criteria

I plan to go to a rehab facility, nursing home, or have home health therapy after discharge.

I am under 18 years old.

I am getting a specific shoulder replacement surgery redone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants are prepared for surgery and download the mymobility app if in the treatment cohort

1 week

1 visit (in-person)

Treatment

Participants undergo reverse total shoulder arthroplasty and begin rehabilitation using either the mymobility app or standard office-based physical therapy

6 months

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mymobility Physical Therapy
• Standard Office-based Physical Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: mymobility Physical Therapy Experimental Treatment 1 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 Therapy Active Control 1 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.

Who Is Running the Clinical Trial?

Campbell Clinic

Lead Sponsor

Trials

15

Recruited

2,100+

American Shoulder and Elbow Surgeons

Collaborator

Trials

3

Recruited

220+

Published Research Related to This Trial

A mobile app designed for patients recovering from shoulder surgery was found to be highly user-friendly, with 97% of respondents reporting it was easy to download and understand the exercises.

The app significantly enhanced patient engagement in their recovery process, with 93% of participants feeling more involved in their treatment and 90% finding the app self-explanatory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usage Evaluation of a Mobile App to Help Understand the Rehabilitation Process of Shoulder Surgery. Giusti, AL., Reginaldo, SDS., Caixeta, TB., et al.[2021]

In a survey of 80 patients who underwent shoulder surgery, 65% reported that their physical therapy sessions contributed to their recovery, attending an average of 16.3 sessions, which highlights the perceived efficacy of traditional in-person physical therapy.

Despite the potential for alternatives like internet-based physical therapy (IBPT), 68.6% of patients expressed reluctance to consider IBPT, indicating a strong preference for in-person therapy and the importance of therapist engagement in the recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' perception of physical therapy after shoulder surgery. Sabesan, VJ., Dawoud, M., Stephens, BJ., et al.[2022]

Citations

1. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/zb-edge/mymobility.html

mymobility A guided orthopedic patient experience, with automation, data and insights for clinicians. mymobility is a digital care management platform that uses iPhone® ...

2. withpower.com withpower.com/trial/phase-reversed-total-shoulder-arthroplasty-7-2023-289e7

App-Based vs Office-Based Physical Therapy for Shoulder ... What data supports the effectiveness of the treatment mymobility Physical Therapy for shoulder surgery? A study found that 97% of patients found a mobile ...

3. odtmag.com odtmag.com/breaking-news/zimmer-biomet-unveils-one-year-data-from-mymobility-clinical-study/

Zimmer Biomet Unveils One-Year Data From mymobility ... The data evaluated 401 patients who underwent total or partial knee arthroplasty. Patients were randomized to a mymobility with Apple Watch ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8888172/

Patients' perception of physical therapy after shoulder ... However, our data find that patients have a perceived preference toward having PT sessions at a rehab center as well as perceiving formal PT over IBPT programs.

5. zimmerbiomet.com zimmerbiomet.com/content/dam/zb-corporate/en/support/health-economics/4760.1-US-en%20mymobility%20US%20Payer%20Dossier_FINAL.pdf

US Payer Dossier ... exercise rehabilitation in the broader physical therapy space. However, a ... Tracking Recovery of Functional and Physical Outcomes with mymobility.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05670080

Does MI Have a Therapeutic Role in Arthroscopic Rotator ... Objective: The aim of this study is to investigate the effect of motor imagery on muscle activity, pain, and function in arthroscopic rotator cuff repair.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1047965122001255

Remote Patient Monitoring of Postoperative Rehabilitation The studies included in this review were low quality but the results showed that there was no difference between telerehabilitation and in-person physical ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05789784?term=SKF-92334&viewType=Table&rank=10

Study of Zimmer Biomet Mymobility Application on Reverse ... This is a trial comparing self-directed rehabilitation using the Zimmer Biomet mymobility digital platform versus standard office-based physical therapy after ...