Use of VirtuaCare™ for home program
OtherUse of VirtuaCare™ system for the Home Program.
NCT Number: NCT06016257
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Cedars-Sinai Medical Center, Los Angeles, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Physical therapy home program subjects
Patients who had usual and customary treatment for acute and chronic shoulder conditions
Exclusion criteria
Physical therapy home program subjects
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
Use of VirtuaCare™ system for the Home Program.
Time frame: 4-8 weeks
Number of participants treatment visits using the VirtuaCare™ platform compared to usual and customary physical therapy treatment
Time frame: 4-8 weeks
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
The participant's number of times to perform the home program as prescribed.
Time frame: Within one month of the participant's last visit.
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.
Contact information is provided by the study sponsor or research team.
Cedars-Sinai Medical Center
Other
Acronym: VirtuaCare
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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