Using VirtuaCareTM Platform for Home Programs in Acute and Chronic Shoulder Conditions: A Pilot Study

NCT06016257 | Recruiting

• 1 other identifier: 00002853
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Shoulder Disease; Shoulder Injuries

Keywords

Home program; Shoulder conditions; Adherence

Outcome Measures

Primary Outcomes (1)

• Reduced Number of Visits

  Number of participants treatment visits using the VirtuaCare™ platform compared to usual and customary physical therapy treatment

  4-8 weeks

Secondary Outcomes (1)

• Improved Functional outcome

  4-8 weeks

Other Outcomes (2)

• Home Program Adherence

  4-8 weeks

• Therapist Feasibility

  Within one month of the participant's last visit.

Study Arms (2)

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.

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.

Interventions

Use of VirtuaCare™ for home program OTHER

Use of VirtuaCare™ system for the Home Program.

VirtuaCare Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Band Connect, Inc: collaborator

Study Sites (2)

Cedars-Sinai Medical Center Outpatient Rehabilitation

Los Angeles, California, 90048, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Shoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Pamela S Roberts, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela S Roberts

CONTACT

18185900004; pamela.roberts@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 29, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)