Virtual Physical Therapy for Shoulder Injuries

(VirtuaCare Trial)

Recruiting at 1 trial location

Overseen By Pamela S Roberts

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Prior surgery, Neurologic comorbidities, Uncontrolled diabetes, Active cancer, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4-8 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will be performed to determine if Band Connect's VirtuaCare™ platform increases patient compliance and provides an effective alternative to current physical therapy treatment while reducing the frequency of visits compared with standard orthopedic physical therapy treatment performed in the outpatient clinic. Participants are being asked to take part in this research study if 18 years and older and have been prescribed physical therapy rehabilitation for an acute or chronic shoulder condition and as part of the participant's physical therapy will receive a shoulder exercise home program.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on physical therapy for shoulder injuries, so it's best to ask the trial coordinators for guidance.

What data supports the effectiveness of the treatment VirtuaCareTM for shoulder injuries?

Research shows that remote rehabilitation and wearable technology can effectively support shoulder recovery. For example, a study on a smart shirt system for shoulder pain demonstrated significant improvements in patient recovery, suggesting that similar virtual platforms like VirtuaCareTM could also be beneficial. ^{1 2 3 4 5}

Is virtual physical therapy for shoulder injuries safe for humans?

The available research does not provide specific safety data for virtual physical therapy for shoulder injuries, but it highlights the usability and patient satisfaction with mobile apps and web-based programs for rehabilitation, suggesting they are generally well-received and easy to use. ^{2 6 7 8 9}

How is virtual physical therapy for shoulder injuries different from other treatments?

Virtual physical therapy for shoulder injuries is unique because it uses virtual reality (VR) technology and telemedicine to deliver personalized rehabilitation programs remotely. This approach allows patients to perform exercises at home under remote supervision, making it more accessible and potentially more engaging than traditional in-person therapy. ^{1 2 3 5 10}

Research Team

Pamela S Roberts, PhD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for adults over 18 who need physical therapy for acute or chronic shoulder conditions and can understand English. It's not suitable for those with recent surgery, uncontrolled diabetes, active cancer in the past two years, or neurological issues affecting function.

Inclusion Criteria

Understand English (exercises are only in English)

I am a physical therapist.

My doctor has prescribed outpatient physical therapy for my shoulder.

Exclusion Criteria

I do not treat acute or chronic shoulder conditions.

I was diagnosed with cancer in the last two years.

I had surgery within the last 5 years or less than 6 months ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the VirtuaCare™ platform for home exercise programs and attend reduced frequency in-clinic visits

4-8 weeks

Periodic in-person visits, continuous virtual monitoring

Follow-up

Participants are monitored for adherence and functional outcomes after treatment

4 weeks

Treatment Details

Interventions

• VirtuaCareTM

Trial Overview The study tests if using the VirtuaCare™ platform at home improves patient compliance and effectiveness of shoulder exercise programs compared to standard outpatient clinic treatments.

Participant Groups

Group I: VirtuaCare Group Experimental Treatment 1 Intervention

For the subjects in Group 1, the physical therapist will set up the patients within the VirtuaCare™ system and build their treatment plan. Each time a patient in the VirtuaCare returns for a clinic visit, the physical therapist will review their VirtuaCare™ patient report displaying information such as exercises completed along with their measured form, pace, range of motion, and exertion. From the review, they will help the patient understand any corrections they need to make in the following week when at home. The therapist can add or adjust any exercises they deem necessary for the next phase of the patient's rehabilitation.

Group II: Usual and Customary Group Active Control 1 Intervention

This study involves a medical record review for the control group. Data will be abstracted from closed medical records after completion of shoulder physical therapy.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Band Connect, Inc

Collaborator

Trials

1

Recruited

20+

Findings from Research

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]

A motion-based machine learning software development kit (SDK) for measuring shoulder motion showed a mean difference of less than 5° compared to traditional goniometer measurements, indicating high accuracy in assessing shoulder range of motion.

The SDK has the potential to be used remotely for monitoring shoulder motion, which could enhance mobile health (mHealth) applications and telemedicine, especially for patients before and after orthopedic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile technology and telemedicine for shoulder range of motion: validation of a motion-based machine-learning software development kit. Ramkumar, PN., Haeberle, HS., Navarro, SM., et al.[2019]

The shift to remote rehabilitation for postoperative shoulder patients has allowed continued access to therapy when in-person visits were not possible, highlighting its importance in the recovery process.

Remote rehabilitation programs offer benefits such as flexibility and accessibility, but they also present challenges, including the need for effective monitoring of patient progress during exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Patient Monitoring of Postoperative Rehabilitation. Erickson, BJ., Shishani, Y., Gobezie, R.[2023]

A randomized controlled trial showed that patients with subacromial pain syndrome using the DAid smart shirt experienced significantly better recovery outcomes compared to a reference group, as measured by standardized tests (p < 0.001).

The DAid smart shirt provides real-time feedback on shoulder motion, helping patients perform exercises more accurately, which enhances muscle control and contributes to improved rehabilitation results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the Recovery of Patients with Subacromial Pain Syndrome with the DAid Smart Textile Shirt. Semjonova, G., Vetra, J., Cauce, V., et al.[2021]

The Shoulphy platform uses wearable technology with inertial sensors to enable remote rehabilitation for shoulder musculoskeletal diseases, allowing for personalized programs supervised by healthcare professionals.

Preliminary tests showed that Shoulphy can effectively distinguish between correct and compensatory movement strategies during shoulder rehabilitation exercises, indicating its potential for improving rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-monitoring and tele-rehabilitation of the shoulder muscular-skeletal diseases through wearable systems. Carbonaro, N., Lucchesi, I., Lorusssi, F., et al.[2020]

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]

The bWell mobile app was developed through focus groups with breast cancer patients, incorporating their preferences for features like tailored information, video demonstrations, and progress tracking to aid in self-management of upper-limb dysfunction after treatment.

Preliminary testing showed that users found the app easy to use and motivating, indicating its potential to support exercise routines for breast cancer survivors, although further research is needed to confirm its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A user-centred approach to developing bWell, a mobile app for arm and shoulder exercises after breast cancer treatment. Harder, H., Holroyd, P., Burkinshaw, L., et al.[2023]

The REWIRE platform for autonomous telerehabilitation demonstrated safety with no adverse events reported during a 12-week study involving 15 stroke patients, indicating it is a secure option for home-based rehabilitation.

Participants showed high compliance with the program, completing an average of 71% of scheduled sessions, and reported excellent acceptance of the system, suggesting it is both effective and well-received for improving balance and gait at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autonomous rehabilitation at stroke patients home for balance and gait: safety, usability and compliance of a virtual reality system. Held, JP., Ferrer, B., Mainetti, R., et al.[2022]

Combining web-based patient education (WBPE) with action and coping plans significantly improved clinic-based adherence to physiotherapy among participants, with a p-value of less than 0.04.

While both groups showed improvements in shoulder function, there was no significant difference in functional outcomes between the WBPE group and the control group, indicating that the WBPE program primarily enhanced adherence rather than functional results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of web-based patient education and action and coping plans as an adjunct to patient treatment in physiotherapy: A randomized controlled trial. Clark, H., Bassett, S., Siegert, R.[2020]

Preliminary data from two ongoing clinical trials suggest that virtual reality (VR) technology may be an effective tool for physical rehabilitation, specifically for improving shoulder joint range-of-motion in patients with chronic frozen shoulder and for balance retraining in individuals recovering from traumatic brain injuries.

If proven effective, VR-based rehabilitation could enhance treatment compliance and motivation, and it may allow for remote therapy options through telehealth, making rehabilitation more accessible to patients in various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental studies of virtual reality-delivered compared to conventional exercise programs for rehabilitation. Sveistrup, H., McComas, J., Thornton, M., et al.[2006]

References

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

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

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

Mobile technology and telemedicine for shoulder range of motion: validation of a motion-based machine-learning software development kit. [2019]

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

Remote Patient Monitoring of Postoperative Rehabilitation. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Improving the Recovery of Patients with Subacromial Pain Syndrome with the DAid Smart Textile Shirt. [2021]

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

Tele-monitoring and tele-rehabilitation of the shoulder muscular-skeletal diseases through wearable systems. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

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

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

A user-centred approach to developing bWell, a mobile app for arm and shoulder exercises after breast cancer treatment. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

Autonomous rehabilitation at stroke patients home for balance and gait: safety, usability and compliance of a virtual reality system. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The effectiveness of web-based patient education and action and coping plans as an adjunct to patient treatment in physiotherapy: A randomized controlled trial. [2020]

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

Experimental studies of virtual reality-delivered compared to conventional exercise programs for rehabilitation. [2006]