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

ConditionsShoulder Disease Shoulder Injuries

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCedars-Sinai Medical Center

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Use of VirtuaCare™ for home program
Other intervention
Use of VirtuaCare™ system for the Home Program.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: VirtuaCare GroupExperimental treatment 1 intervention

Group B: Usual and Customary GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Reduced Number of Visits

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

Time frame

4-8 weeks

Secondary outcomes

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.

Time frame

4-8 weeks

Other outcomes

Home Program Adherence

The participant's number of times to perform the home program as prescribed.

Time frame

4-8 weeks

Therapist Feasibility

The therapist's score on feasibility instrument using the VirtuaCare™ platform. The scores range from 1 strongly agree to 5 strongly disagree. The lower the score the better.

Time frame

Within one month of the participant's last visit.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

Band Connect, Inc

Collaborator

Source ClinicalTrials.gov

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