South Kingstown

This research aims to collect ongoing safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis used by patients with lower extremity pareses. The study follows patients who have been casted for a C-Brace fitting and consent to participate, focusing on documenting their progress and experiences over time with this device. The C-Brace device includes custom thigh, calf, and foot components connected by an ankle joint and sensor system that continuously monitors knee joint movement. This allows the device to adjust resistance and control knee flexion and extension during walking. Participants will receive standard care including baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after final fitting. Participants will undergo assessments such as walking speed tests, mobility and balance evaluations, and balance confidence questionnaires to measure changes from baseline. The study also tracks device-related adverse events, especially falls, to monitor safety over 12 months and beyond. The total follow-up period extends up to 36 months to provide comprehensive data on long-term use.

Researchers are evaluating Native PATHS, a culturally adapted prevention program designed for Indigenous youth in 5th to 8th grade to reduce early initiation and use of alcohol, tobacco, and other drugs. This project addresses significant health disparities related to alcohol use among Indigenous populations in the US and Canada, focusing on a strengths-based, family-centered approach guided by behavioral economic and positive psychological theories. The program aims to delay substance use initiation by promoting alternative activities and reinforcing positive emotions and life satisfaction. The Native PATHS program involves working with youth and their families to establish substance-free rules, reduce availability of substances at home, and encourage engagement in alternative, substance-free activities. Initial stages include talking circle sessions with youth and family members for feedback, followed by an open-label pilot and a randomized controlled trial comparing Native PATHS to a wait-list control group. The study includes qualitative and quantitative feedback collection from participants after each session to adapt and evaluate the program. Participants will be involved in multiple assessment points, including surveys measuring past month and past three-month use of alcohol, marijuana, and cigarettes, as well as intentions to use these substances at baseline, end of treatment (up to 12 weeks after baseline), and six months post-treatment. The study also evaluates mechanisms such as future orientation and reinforcement from alternative activities, with safety monitoring and long-term follow-up to assess the program's acceptability, feasibility, and initial efficacy. Youth and family member participation spans from initial feedback sessions through the pilot and randomized trial phases.

Researchers are collecting data on the IlluminOss Device, which is used to stabilize and align traumatic or pathological fractures. This multi-center registry study gathers safety and performance information to better understand how the device works in real-world medical care. Both retrospective and prospective patient data are included to provide a comprehensive overview. Patients in the registry either have already received or will receive the IlluminOss device as part of their fracture treatment. Medical data is collected during standard care visits, starting at the initial clinic visit. Patient information includes demographics, surgical details, hospital discharge data, and any adverse events. Patients complete questionnaires including PROMIS physical function, Visual Analog Pain Score, and Veterans Rand 12 surveys before surgery and at follow-up visits of 75 days, 6 months, and 12 months. During the study, participants follow scheduled clinical and radiographic evaluations to monitor outcomes and safety. Researchers track patient-reported outcomes and adverse events to assess the device's performance over time. The study focuses on the composite safety success rate measured at 12 months, helping to provide long-term data on the device's use in fracture treatment.

This research aims to assess patient outcomes after shoulder replacement surgery using FX Shoulder Solutions medical devices. The study focuses on evaluating the effectiveness, safety, and long-term survivorship of these devices in patients with shoulder conditions such as osteoarthritis, rotator cuff syndrome, and shoulder fractures. The data collected will support regulatory requirements and be used for scientific presentations and publications. Participants receive one of several FX Artificial Shoulder Prosthesis devices, including the Humelock II Anatomic, Humelock II Reversible, Humelock Reverse, Humeris, Easytech Anatomical, FXV135 Mini, or FXV135 Humelock Shoulder Systems. These devices are legally marketed in the USA and implanted according to each device's indications for use. The study tracks patients over an extended period to monitor device performance and patient health. Patients are followed for at least 2 years post-surgery to determine success by a composite clinical measure that includes improved shoulder function, absence of device complications such as migration or radiolucency, no revision surgeries, and no serious device-related adverse events. The study continues monitoring patients up to 10 years to evaluate device survivorship and long-term outcomes.

Researchers are evaluating a technology-based collaborative care program called RI-SPHERES for postpartum people with hypertensive disorders of pregnancy. The trial aims to compare RI-SPHERES to a standard self-measured blood pressure program to see if it is not worse in controlling persistent high blood pressure six weeks after childbirth and improving preventive care visits within one year. The study addresses gaps in current blood pressure monitoring programs, especially for racial and ethnic minority groups who face barriers to in-person care. Participants are randomly assigned to either the RI-SPHERES group or the standard program group. The RI-SPHERES group learns to use a Bluetooth-enabled blood pressure cuff that syncs with an app providing automated reminders, educational content, and two-way communication with care managers for one year postpartum. The care manager supports participants with social needs and facilitates preventive care appointments after six weeks. The standard program involves self-measuring blood pressure and reporting it through a patient portal with reminders and recommendations for follow-up care at six weeks postpartum. During the study, participants will perform regular blood pressure measurements and communicate with care teams through the assigned program. Researchers will track persistent hypertension at six weeks postpartum and preventive care attendance within one year. The study includes assessments of equity based on race, ethnicity, language, and geography. The total participation covers one year postpartum, with ongoing support and monitoring to reduce health complications related to hypertensive disorders of pregnancy.