Band Connect for Shoulder Surgery Recovery

Overseen By Kira Smith, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Hemiarthroplasty, Revision TSA, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

499 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how effectively a platform called Band Connect aids adherence to exercise routines after shoulder surgery. It targets individuals undergoing either total shoulder replacement or rotator cuff repair who will attend physical therapy afterward. The study compares participants using Band Connect with those receiving standard care to determine if the platform enhances patient involvement and satisfaction. Patients who have undergone shoulder surgery with Dr. Robert Gillespie and are participating in physical therapy at University Hospitals may qualify. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve recovery experiences for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Band Connect platform is safe for use in shoulder surgery recovery?

Research has shown that Band Connect, a health platform, has been used in studies to evaluate its effectiveness in helping people adhere to their home exercise routines. In one small study, participants using Band Connect followed their exercise plans more consistently.

Regarding safety, Band Connect is a digital tool, not a medicine or surgery, so it does not carry the usual concerns about side effects or physical harm. The platform tracks exercises and progress, making it generally safe to use. However, it is important to follow instructions and avoid overexertion during exercises, as pushing too hard could impact recovery.

For concerns about using Band Connect or recovery, consulting a doctor or physical therapist is advisable. They can ensure that everything is safe and appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for shoulder surgery recovery, which often rely on physical therapy and exercise programs, Band Connect is a digital platform that allows patients to build and personalize their recovery plans from their initial clinic visit. Researchers are excited about Band Connect because it leverages technology to offer a more tailored approach to rehabilitation, potentially increasing patient engagement and improving recovery outcomes. This platform could transform how recovery is managed by providing real-time feedback and adjustments, making the process more interactive and efficient for both patients and healthcare providers.

What evidence suggests that Band Connect is effective for enhancing compliance with home exercise programs?

Research shows that Band Connect, a health platform linking patients and doctors, can enhance recovery after shoulder surgery. In this trial, participants in Group 1 will use the Band Connect platform to develop their treatment plan. Studies have found that tools like Band Connect simplify adherence to physical therapy exercises, which is crucial for recovery. In one study, 96% of patients reported that Band Connect aided their shoulder recovery, with 71% experiencing less pain and 92% feeling less stiffness. These results indicate that Band Connect helps patients stay on track with their exercises and improves recovery. Overall, these findings suggest that Band Connect enhances the rehabilitation process for those who have undergone shoulder surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Robert Gillespie, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals undergoing total shoulder replacement or rotator cuff repair who will participate in physical therapy. It aims to include those willing to use the Band Connect health platform during their home exercise programs.

Inclusion Criteria

Chart Review Inclusion Criteria:

I had a primary shoulder replacement surgery.

My surgery was done by Dr. Robert Gillespie and I had physical therapy at University Hospitals.

Exclusion Criteria

I stayed in the hospital for more than 3 days after my shoulder surgery.

I am having a second surgery on my rotator cuff.

Shoulder injuries related to workers compensation or involved in any pending litigation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo physical therapy rehabilitation using the Band Connect platform or standard care

6 months

Regular in-person and virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Band Connect

Trial Overview

The study tests Band Connect, a digital tool designed to improve patient adherence to prescribed home exercises post-surgery. The goal is to see if it boosts engagement and satisfaction, and whether it can increase revenue per patient.

How Is the Trial Designed?

Group I: Group 1 Band Connect Experimental Treatment 1 Intervention

Patients in group 1 will be set up with the Band Connect platform and build their treatment plan at the first in-clinic visit.

Group II: Group 2 Standard Care Active Control 1 Intervention

Group 2 will consist of retrospective chart review to as act a control group. Charts will be pulled from 1/1/2019-12/31/2023.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Band Connect

Collaborator

Trials

1

Recruited

500+

Published Research Related to This Trial

A survey of 350 NHS shoulder surgeons in the UK revealed that 79% use outcome measures in their practice, with the Oxford shoulder score being the most popular among them, utilized by 69% of respondents.

The study highlights the importance of adopting validated outcome measures across all surgical specialties to improve treatment assessments and enhance transparency in surgical performance evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of shoulder scoring systems and outcome measures in the UK. Varghese, M., Lamb, J., Rambani, R., et al.[2021]

The study presents a straightforward technique for restraining the shoulder after injury or surgery, which may enhance patient comfort and recovery.

This method aims to provide effective immobilization, potentially improving healing outcomes for patients with shoulder injuries or post-operative conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple shoulder restraint. Williamson, JB.[2019]

The application of Enhanced Recovery After Surgery (ERAS) protocols in laparoscopic bariatric surgery significantly reduces both operative time and length of hospital stay, based on a meta-analysis of 7 studies involving 3264 patients.

There were no significant differences in the rates of major or minor postoperative complications, readmissions, or reoperations between patients receiving ERAS management and those receiving traditional care, indicating that ERAS is a safe approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Meta-analysis on safety of application of enhanced recovery after surgery to laparoscopic bariatric surgery]. Wang, W., Yang, C., Wang, B.[2019]

In a study of 60 patients who underwent arthroscopic rotator cuff repair, those receiving Enhanced Recovery After Surgery (ERAS) nursing combined with limb training showed significantly improved shoulder joint range of motion and neurological function compared to those receiving routine nursing.

The experimental group reported lower pain and swelling, higher self-efficacy, and a lower complication rate, indicating that ERAS nursing combined with rehabilitation training is more effective for recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of evidence-based nursing combined with enhanced recovery after surgery on shoulder joint function and neurological function after arthroscopic rotator cuff injury repair. He, L., Li, Y., Liao, X., et al.[2023]

This study aims to enhance postoperative recovery by using activity trackers to provide continuous feedback on step counts for patients undergoing major abdominal surgeries, with a total of 120 participants randomized into groups with and without feedback.

The primary goal is to increase the average step count during the first 5 postoperative days, addressing the challenge of objectively measuring and implementing early mobilization in clinical practice, which is crucial for successful recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of activity tracking in major visceral surgery-the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial. Wolk, S., Meißner, T., Linke, S., et al.[2018]

A study of 71 patients who underwent rotator cuff surgery found that both day-hospitalization and in-patient rehabilitation provided similar outcomes in terms of pain, range of motion, and complications, indicating that either option can be effective for recovery.

However, patients who had more complex surgeries experienced higher levels of pain and stiffness by the fifteenth day post-surgery, suggesting that the complexity of the surgery may influence early recovery experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rehabilitation after shoulder rotator cuff surgery: in-patient or day-hospitalization (about 76 cases)]. Delbrouck, C., Dauty, M., Huguet, D., et al.[2021]

Adverse events in surgical departments are mostly registered, with 92.5% of departments reporting such events, although 42.7% still rely on paper methods instead of digital systems.

The National Surgical Adverse Event Registration (LHCR) software is currently operational in only 24.6% of departments, primarily due to challenges in creating an import file from hospital information systems, indicating a significant opportunity for improvement and wider implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Automated registration of adverse events in surgical patients in the Netherlands: the current status]. Marang-van de Mheen, PJ., Kievit, J.[2015]

Out of 409,991 patients who underwent soft tissue reconstructive procedures from 2005 to 2010, 4.06% experienced adverse events (AEs), indicating that while AEs are not uncommon, the overall rates are lower compared to other surgical disciplines.

Certain patient characteristics, such as older age, male gender, nonwhite ethnicity, and reliance on public insurance, were associated with higher rates of AEs, highlighting the need for targeted quality improvement efforts in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in plastic surgery: identifying areas for quality improvement efforts. Hernandez-Boussard, T., McDonald, KM., Rhoads, KF., et al.[2022]

In a study involving 281 morbidly obese patients undergoing bariatric surgery, the use of an Internet application for at-home follow-up successfully detected all early complications, demonstrating its safety and effectiveness.

Out of 264 patients who completed the 10-day follow-up, only 1.1% required surgical revision for complications, indicating that the connected surveillance protocol was effective in monitoring patient recovery and ensuring high satisfaction rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connected Surveillance for Detection of Complications After Early Discharge from Bariatric Surgery. Neuberg, M., Blanchet, MC., Gignoux, B., et al.[2021]

A new web-based system called PROMs 2.0 was developed to facilitate the administration of patient-reported outcome measures, allowing patients to track their progress, specifically focusing on those undergoing arthroscopic subacromial decompression using the Oxford shoulder score (OSS).

In a pilot study, 83% of eligible patients who showed improvement in their OSS chose to skip routine follow-up appointments, indicating that the system may enhance patient satisfaction and reduce clinic visits while still monitoring recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures: an on-line system empowering patient choice. Wilson, J., Arshad, F., Nnamoko, N., et al.[2021]

The implementation of the Enhanced Recovery After Surgery (ERAS) program in spinal fusion procedures significantly reduced the average hospital length of stay (LOS) for patients, with reductions from 6.06 to 3.33 days for anterior lumbar interbody fusion (ALIF), 3.08 to 1.3 days for anterior cervical discectomy and fusion (ACDF), and 6.7 to 4.8 days for posterior fusion cases, all with p-values < 0.001.

Despite the reduced LOS, the ERAS program did not lead to an increase in overall complications, and patient satisfaction with care management was high, with 86.5% of surveyed patients expressing satisfaction with the care received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Enhanced Recovery After Surgery for fusion in degenerative spine surgery: impact on outcome, length of stay, and patient satisfaction. Debono, B., Corniola, MV., Pietton, R., et al.[2020]

The use of smartbands in a perioperative ERAS program for minimally invasive colorectal surgery did not significantly improve compliance with early mobilization or reduce postoperative complications compared to standard protocols.

However, smartbands enhanced communication and self-management, leading to a quicker return to preoperative functional status and a reduction in hospital stay by approximately 1 day for patients without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartband Use During Enhanced Recovery After Surgery Facilitates Inpatient Recuperation Following Minimally Invasive Colorectal Surgery. Yin, TC., Huang, CW., Tsai, HL., et al.[2021]

The ClassIntra system demonstrated an almost perfect inter-rater agreement (Cohen Kappa coefficient of 0.87) for grading intraoperative adverse events (iAEs) in elective abdominal surgeries, indicating it is a reliable tool for assessing surgical complications.

Higher severity grades in ClassIntra were linked to an increased risk of postoperative complications, with intraoperative hypotension and organ injuries being the strongest predictors, highlighting the importance of monitoring these events during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inter-Rater Agreement of the Classification of Intraoperative Adverse Events (ClassIntra) in Abdominal Surgery. Krielen, P., Gawria, L., Stommel, MWJ., et al.[2023]

Anatomic total shoulder arthroplasty patients using a neutral rotation sling position experienced less night pain and improved range of motion, supported by moderate evidence from the review of 14 studies.

The review highlighted that many factors influencing treatment outcomes, such as telemedicine and immediate range of motion exercises, had only preliminary or conflicting evidence, indicating a need for more standardized and high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with better treatment outcome of physical therapy interventions after shoulder arthroplasty: A systematic review. Claes, A., Mertens, MG., Verborgt, O., et al.[2022]

Patients undergoing shoulder arthroplasty at an orthopedic specialty hospital (OSH) had a significantly shorter average length of stay (1.31 days) compared to those at a tertiary referral center (TRC) (1.85 days), despite similar patient characteristics across both groups.

Readmission rates were comparable between the OSH (1.5%) and TRC (0.7%), suggesting that the shorter hospital stay at the OSH did not compromise patient safety or outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Length of stay after shoulder arthroplasty-the effect of an orthopedic specialty hospital. Padegimas, EM., Zmistowski, BM., Clyde, CT., et al.[2018]

Citations

1.

app.trialscreen.org

app.trialscreen.org/trials/innovating-physical-therapy-pilot-on-band-connect-s-impact-compliance-trial-nct06733480

A Pilot Study on Band Connect's Impact on Compliance ...

Benefits: Participation in this study may lead to improved adherence to physical therapy exercises, increased engagement with the rehabilitation process, and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10293560/

Self-Reported Outcomes in Early Postoperative ...

The use of SSS with telehealth revealed a positive impact on postoperative shoulder rehabilitation (96%), pain (71%), and stiffness (92%) as reported by ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666061X23001335

Validated Wearable Device Shows Acute Postoperative ...

The rate of device compliance in the RCR group decreased from 84% at surgery to 46% by 6 weeks postoperatively (P < .001). Similarly, the rate of device ...

4.

josr-online.biomedcentral.com

josr-online.biomedcentral.com/articles/10.1186/s13018-024-04986-4

The effects of telemedicine on Rotator cuff-related shoulder ...

Evidence has shown that telemedicine can alleviate shoulder pain and stiffness in the early period after shoulder surgery and improve shoulder ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11965055/

Rehabilitation and Long Term Outcomes Including Return ...

In data collected from 12 studies, patients returned to work an average of 2.3 ± 2.4 months after rTSA and 1.93 ± 3.74 months after aTSA.

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S1360859225000178

Elastic band resistance for shoulder rehabilitation

If the individual cannot quantify how much force they are applying, they may exceed safe limits and compromise the biological healing of the repair site.

7.

arthroscopysportsmedicineandrehabilitation.org

arthroscopysportsmedicineandrehabilitation.org/article/S2666-061X(23)00133-5/fulltext

Validated Wearable Device Shows Acute Postoperative ...

Male and female adult patients undergoing either RCR or TSA were followed up from 34 days preoperatively to 6 weeks postoperatively.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10212553/

Assessment of Safety, Efficacy, and Functional Outcomes ...

This study aimed to assess the safety, efficacy, and functional outcomes after RCT repair using Ceptre® titanium screw anchor implants.