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

Recruiting 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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a trial comparing self-directed rehabilitation using the Zimmer Biomet mymobility digital platform versus standard office-based physical therapy after reverse shoulder replacement. The investigators hypothesize that there will be no difference in the postoperative outcomes between the mymobility cohort and the standard office-based physical therapy cohort.

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 data supports the effectiveness of the treatment mymobility Physical Therapy for shoulder surgery?

A study found that 97% of patients found a mobile app for shoulder surgery rehabilitation easy to use and helpful in understanding their treatment, suggesting that app-based physical therapy can effectively support recovery by enhancing patient engagement and understanding. ^{1 2 3 4 5}

Is app-based physical therapy safe for shoulder surgery recovery?

The research does not provide specific safety data for app-based physical therapy, but a study found that 97% of users found the app easy to use and 90% considered it self-explanatory, suggesting it is user-friendly and well-received by patients. ^{1 2 3 4 6}

How does the app-based physical therapy treatment differ from standard office-based physical therapy for shoulder surgery?

The app-based physical therapy treatment is unique because it allows patients to perform exercises at home using a mobile app, which provides guidance and helps them feel more involved in their recovery. This approach offers convenience and accessibility, making it easier for patients to manage their rehabilitation process compared to traditional office-based physical therapy. ^{1 2 4 5 7}

Research Team

Tyler J Brolin, MD

Principal Investigator

Campbell Clinic

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Usage Evaluation of a Mobile App to Help Understand the Rehabilitation Process of Shoulder Surgery. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Patients' perception of physical therapy after shoulder surgery. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Digital physical therapy practice and payment during the COVID-19 pandemic: A case series. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile Health Applications for Rehabilitation of Musculoskeletal Diseases of the Shoulder: A Systematic Analysis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Agreement between patient-based and clinician-based assessment of the shoulder. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Modified Outpatient Physical Therapy Improvement in Movement Assessment Log (mOPTIMAL): A Responsive and Reliable Tool for Patients with Non-Operative Shoulder Pain. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Motions and functional performance after supervised physical therapy program versus home-based program after arthroscopic anterior shoulder stabilization: a randomized clinical trial. [2014]