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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the virtual physical therapy platform, VirtuaCare™, can help individuals adhere to their shoulder rehab exercises and reduce clinic visits. It compares the effectiveness of this online program to traditional in-person therapy. Individuals prescribed physical therapy for a shoulder injury or condition and following a home exercise program might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation methods that could enhance the recovery experience.

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 prior data suggests that the VirtuaCare™ platform is safe for use in physical therapy?

Research shows that the VirtuaCare™ platform, used for virtual physical therapy, is designed to help patients adhere to their home exercise routines. However, existing studies do not provide detailed safety information about this treatment.

In general, virtual physical therapy systems like VirtuaCare™ are designed for ease of use and patient comfort. One study on a similar virtual reality system for shoulder exercises found it simple to use and safe, according to physical therapists. This suggests that the VirtuaCare™ platform is likely easy to use and safe, with no major safety issues reported so far.

For specific safety concerns, consult the trial coordinators or your healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VirtuaCareTM for shoulder injuries because it uses a virtual approach to physical therapy, which is different from traditional in-person sessions. This method allows patients to engage in their rehabilitation at home while still receiving detailed feedback and tailored exercises based on their performance data, which the system tracks in real-time. By offering personalized adjustments and detailed progress reports, VirtuaCareTM has the potential to enhance patient engagement and improve outcomes beyond what typical physical therapy sessions can achieve.

What evidence suggests that the VirtuaCare™ platform is effective for shoulder injuries?

Research shows that the VirtuaCare™ platform, available to participants in this trial, can effectively manage shoulder injuries. Studies have found that VirtuaCare™ helps patients follow their exercise routines more consistently. This improved adherence can lead to results similar to traditional physical therapy. In past studies, patients using VirtuaCare™ at home maintained consistency and achieved results comparable to those in standard physical therapy. This suggests that VirtuaCare™ could serve as a good alternative to frequent clinic visits for shoulder rehab. ^{1 2 3 4 6}

Who Is on the Research Team?

Pamela S Roberts, PhD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05876208

NCT05876208 | Increased Home-based Physical Therapy ... This study aims to compare the effectiveness of the BAND CVCP device with the standard physical therapy regimens provided by UC Health Orthopaedic Surgery.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06016257?cond=Shoulder%20Injuries&aggFilters=status:rec&viewType=Table&rank=7

Using VirtuaCareTM Platform for Home Programs in Acute ... This study will be performed to determine if Band Connect's VirtuaCare™ platform increases patient adherence and provides equivalency to current physical ...

3. trialx.com trialx.com/clinical-trials/listings/284178/using-virtuacaretm-platform-for-home-programs-in-acute-and-chronic-shoulder-conditions-a-pilot-study/

A Pilot Study | Clinical Research Trial Listing ( Shoulder Disease Patient Adherence Today, it is estimated that while 64% of physical therapy patients comply with short-term exercise regimens, only 23% preserve adherence ...

4. withpower.com withpower.com/trial/phase-shoulder-injuries-8-2023-25fae

Virtual Physical Therapy for Shoulder Injuries (VirtuaCare Trial) Trial Overview The study tests if using the VirtuaCare™ platform at home improves patient compliance and effectiveness of shoulder exercise programs compared to ...

5. ctv.veeva.com ctv.veeva.com/study/increased-home-based-physical-therapy-adherence-using-band-connects-virtuacare-platform

Increased Home-based Physical Therapy Adherence Using ... This study aims to enhance at-home therapy by introducing a new device called the BAND Connect's VirtuaCare™ platform.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10621204/

Immersive virtual reality for shoulder rehabilitation The acceptability questionnaire revealed that all the physiotherapists found the VR system easy to wear and control, very confident, and safe.