Shoulder DiseaseVirtuaCareNCT06016257
Using VirtuaCareTM Platform for Home Programs in Acute and Chronic Shoulder Conditions: A Pilot Study
A study testing Use of VirtuaCare™ for home program in people with Shoulder Disease and Shoulder Injuries, run by Cedars-Sinai Medical Center at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Disease, Shoulder Injuries
- What is being tested?
- Use of VirtuaCare™ for home program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical therapy home program subjects
- Subject 18 years or older
- Outpatient physical therapy prescribed by doctor for shoulder rehabilitation.
- No previous neurological condition
- Understand English (exercises are only in English) Physical therapists
- The therapists will be the ones who provide physical therapy treatment to the acute and chronic shoulder population.
- Patients who had usual and customary treatment for acute and chronic shoulder conditions
- Any patient referred based on inclusion criteria noted above that are referred for outpatient physical therapy and had a previous acute or chronic shoulder condition, were 18 years and older and had no previously documented neurological condition.
Who cannot join
- Physical therapy home program subjects
- Prior surgery within the last 5 years or less than 6 months between surgery
- Neurologic comorbidities that have functional deficits
- Uncontrolled diabetes
- Diagnosis with active cancer in the last two years
- Unable to understand English
Show all 9Show fewer
- Physical therapists • Any therapist who does not provide physical therapy treatment for acute and chronic shoulder conditions.
- Patients who had usual and customary treatment for acute and chronic shoulder conditions
- Any patient who had prior surgery within the last 5 years or less than 6 months between surgery, had neurological comorbidities that had documented functional deficits, documented uncontrollable diabetes, documented diagnosis of active cancer within the last two years.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cedars-Sinai Medical Center Outpatient Rehabilitation
Los Angeles, California, 90048
Pamela Roberts, PhD
Pamela Roberts, PhD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Pamela S Roberts, PhD, 18185900004, pamela.roberts@cshs.org
Jeffrey Wertheimer, PhD, Jeffrey.wertheimer@cshs.org
About this study
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.
Read the detailed description
In today's environment, review of a patient's rehabilitation progress and recovery is limited to in-person, one-on-one clinic visits with their therapist periodically. While these sessions are typically well-defined and comprehensive, there are no mechanisms currently available to help the clinicians and therapists to effectively engage with patients when they are not in the clinic.
Patients are prescribed at-home exercises after each visit and the therapists have no line of sight as to how the patient is progressing or if the patient is even adhering to the treatment plan. The patient typically receives some rudimentary instruction about how an exercise or treatment needs to be performed, a setup that can result in unknown adherence and/or poor form. There are also no mechanisms for active feedback to the patient about any aspect of their treatment of recovery - e.g., whether the patient is doing better or worse. These gaps and inconsistencies result in a circumstance wherein less than 35% of patients typically adhere to their prescribed plans of care.
Patient Adherence Today, it is estimated that while 64% of physical therapy patients comply with short-term exercise regimens, only 23% preserve adherence throughout their physical therapy treatment. While this number seems accurate, these percentages are still unknown because patients typically do not admit non-compliance and adherence is typically not measured objectively [6]. Results from a study examining at-home adherence for patients with chronic low back pain indicate that barriers include "the exercise program (number, effectiveness, complexity and burden of exercises), the healthcare journey (breakdown between supervised sessions and home exercise, lack of follow-up and difficulties in contacting care providers), patient representations (illness and exercise perception, despondency, depression and lack of motivation), and the environment (attitudes of others, difficulties in planning exercise practice) [4]." Conversely, the study found that opportunities to increase adherence include improving patient performance through feedback capabilities and increased support from care providers. The study concluded that new technologies have the potential to meet these barriers and are attractive to patients but only if the technology is not a substitute for in-person relationship between the patients and care providers [4]. Unlike technologies currently on the market that focus solely on virtual environments, the VirtuaCare™ platform provides a tool for physical therapists to supplement their in-person treatment with a higher-caliber experience outside of the clinic environment.
Band Connect will address some of these constraints by using digital health technology in conjunction with a personalized simulation of each exercise, allowing patients to adopt the correct form, review progress, and receive continuous real-time instruction through a visual mechanism. Additionally, the physical therapist can remotely review the patient's progress on the platform in an objective manner and adjust their treatment plan accordingly.
This study, specifically, will focus both on measuring the effectiveness of VirtuaCare™ to drive towards higher adherence rates while providing the usual and customary orthopedic physical therapy with a platform that allows for lower frequency of in-clinic visits over the typical outpatient rehabilitation duration. This is an incredibly relevant and important consideration in the current healthcare environment.
This study will be performed to determine if Band Connect's VirtuaCare™ platform increases patient adherence and provides equivalency to current physical therapy treatment while reducing frequency of visits compared with standard orthopedic physical therapy treatment performed in the outpatient clinic The study will measure and collate a variety of data points with patients using VirtuaCare™ and compare these to a historical control group of patients with the same orthopedic conditions.
- Conditions
- Shoulder Disease, Shoulder Injuries
- Being tested
- Use of VirtuaCare™ for home program
- Keywords
- Home program, Shoulder conditions, Adherence
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of VirtuaCare™ for home programOther
Use of VirtuaCare™ system for the Home Program.
| Study group | Role | What they receive |
|---|---|---|
| VirtuaCare Group | Experimental | 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. Receives: Other: Use of VirtuaCare™ for home program |
| Usual and Customary Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced Number of Visits
Number of participants treatment visits using the VirtuaCare™ platform compared to usual and customary physical therapy treatment
Measured: 4-8 weeks
Secondary outcomes (1)
Improved Functional outcome
Participants score on the Upper Extremity Functional Index using the VirtuaCare™ platform compared to usual and customary physical therapy treatment score on the Upper Extremity Functional Index (UEFI). Scores range from 0 to 4, 0 indicates extreme difficulty while 4 indicates no difficulty with a task. Possible range on the 20-item UEFI is from 0-80 with 0 indicating lowest functional status and 80 indicating highest functional status. The higher the score, the better the functional status. The minimum amount of change that is considered to be clinically significant is 9 points.
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- At the first physical therapy appointment, subjects in Group 1 will be given access to and provided necessary materials for the VirtuaCare™ platform to use as an adjunct for the prescribed shoulder exercises when at home. Whereas Group 2's information will be obtained via a retrospective chart review. 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 Group 1 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Band Connect, Inc
- Responsible party
- Principal investigator, Pamela Roberts, Cedars-Sinai Medical Center
- Investigators
- Pamela S Roberts, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016257
- Sponsor's protocol ID
- 00002853
- Acronym
- VirtuaCare
- Status last verified
- Mar 2026
- First submitted
- 10 Aug 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data except with patient during treatment
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using VirtuaCareTM Platform for Home Programs in Acute and Chronic Shoulder Conditions: A Pilot Study
- ClinicalTrials.gov ID
- NCT06016257
- Acronym / sponsor ID
- VirtuaCare / 00002853
- Conditions
- Shoulder Disease, Shoulder Injuries
- Keywords
- Home program, Shoulder conditions, Adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Band Connect, Inc
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In today's environment, review of a patient's rehabilitation progress and recovery is limited to in-person, one-on-one clinic visits with their therapist periodically. While these sessions are typically well-defined and comprehensive, there are no mechanisms currently available to help the clinicians and therapists to effectively engage with patients when they are not in the clinic.
Patients are prescribed at-home exercises after each visit and the therapists have no line of sight as to how the patient is progressing or if the patient is even adhering to the treatment plan. The patient typically receives some rudimentary instruction about how an exercise or treatment needs to be performed, a setup that can result in unknown adherence and/or poor form. There are also no mechanisms for active feedback to the patient about any aspect of their treatment of recovery - e.g., whether the patient is doing better or worse. These gaps and inconsistencies result in a circumstance wherein less than 35% of patients typically adhere to their prescribed plans of care.
Patient Adherence Today, it is estimated that while 64% of physical therapy patients comply with short-term exercise regimens, only 23% preserve adherence throughout their physical therapy treatment. While this number seems accurate, these percentages are still unknown because patients typically do not admit non-compliance and adherence is typically not measured objectively [6]. Results from a study examining at-home adherence for patients with chronic low back pain indicate that barriers include "the exercise program (number, effectiveness, complexity and burden of exercises), the healthcare journey (breakdown between supervised sessions and home exercise, lack of follow-up and difficulties in contacting care providers), patient representations (illness and exercise perception, despondency, depression and lack of motivation), and the environment (attitudes of others, difficulties in planning exercise practice) [4]." Conversely, the study found that opportunities to increase adherence include improving patient performance through feedback capabilities and increased support from care providers. The study concluded that new technologies have the potential to meet these barriers and are attractive to patients but only if the technology is not a substitute for in-person relationship between the patients and care providers [4]. Unlike technologies currently on the market that focus solely on virtual environments, the VirtuaCare™ platform provides a tool for physical therapists to supplement their in-person treatment with a higher-caliber experience outside of the clinic environment.
Band Connect will address some of these constraints by using digital health technology in conjunction with a personalized simulation of each exercise, allowing patients to adopt the correct form, review progress, and receive continuous real-time instruction through a visual mechanism. Additionally, the physical therapist can remotely review the patient's progress on the platform in an objective manner and adjust their treatment plan accordingly.
This study, specifically, will focus both on measuring the effectiveness of VirtuaCare™ to drive towards higher adherence rates while providing the usual and customary orthopedic physical therapy with a platform that allows for lower frequency of in-clinic visits over the typical outpatient rehabilitation duration. This is an incredibly relevant and important consideration in the current healthcare environment.
This study will be performed to determine if Band Connect's VirtuaCare™ platform increases patient adherence and provides equivalency to current physical therapy treatment while reducing frequency of visits compared with standard orthopedic physical therapy treatment performed in the outpatient clinic The study will measure and collate a variety of data points with patients using VirtuaCare™ and compare these to a historical control group of patients with the same orthopedic conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At the first physical therapy appointment, subjects in Group 1 will be given access to and provided necessary materials for the VirtuaCare™ platform to use as an adjunct for the prescribed shoulder exercises when at home. Whereas Group 2's information will be obtained via a retrospective chart review. 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 Group 1 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.
| Arm | Type | Receives |
|---|---|---|
| VirtuaCare Group | Experimental | Other: Use of VirtuaCare™ for home programFor 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. |
| Usual and Customary Group | No 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Physical therapy home program subjects
- Subject 18 years or older
- Outpatient physical therapy prescribed by doctor for shoulder rehabilitation.
- No previous neurological condition
- Understand English (exercises are only in English) Physical therapists
Key exclusion criteria (9 listed)
- Physical therapy home program subjects
- Prior surgery within the last 5 years or less than 6 months between surgery
- Neurologic comorbidities that have functional deficits
- Uncontrolled diabetes
- Diagnosis with active cancer in the last two years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of VirtuaCare™ for home programUse of VirtuaCare™ system for the Home Program. | Other | VirtuaCare Group |
Primary outcome
Reduced Number of Visits
Time frame: 4-8 weeks
Number of participants treatment visits using the VirtuaCare™ platform compared to usual and customary physical therapy treatment
1 secondary outcome
Improved Functional outcome
Time frame: 4-8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. No plan to share data except with patient during treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pamela S Roberts, PhD principal investigator
Cedars-Sinai Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of VirtuaCare™ for home program in people with Shoulder Disease and Shoulder Injuries, run by Cedars-Sinai Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela S Roberts (18185900004, pamela.roberts@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced Number of Visits (time frame: 4-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.