Clinical Research Directory

Evaluation of a Voice-Activated Call Light System for Clients With Limited Upper-Extremity Mobility

The goal of this study is to evaluate whether a voice-activated call light system enables people in a rehabilitation facility who have limited use of their arms and hands to call for help more independently and reliably than with their previous call light access method. The study will also examine client confidence, family confidence and peace of mind, staff confidence, staff effort, system reliability, and the level of disruption to routine care. The main questions to be answered are: 1. People with what etiologies benefit most from access to the voice-activated call light system? 2. How reliable is the voice-activated call light system in alerting staff to a client's need for assistance? 3. How confident are clients, family members, and staff in the reliability of the voice-activated system for alerting staff of a client's need for assistance? 4. How does access to the voice-activated call light system compare to traditional call light systems regarding staff effort and disruption to routine care? Participants with limited upper extremity movement will use the voice-activated call light system as needed during normal daily activities for up to 90 days. At study initiation, clients with limited upper extremity movement, staff members working with those clients, and family members of the clients will complete a brief questionnaire about their experiences using the existing call light system. At approximately Days 30, 60, and 90, they will complete brief questionnaires about use of the voice-activated call light system and its effectiveness.

Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI

Treatment for sublesional bone loss (osteoporosis) in persons with chronic, motor-complete spinal cord injury (SCI) has been limited and unsuccessful to date. Romosozumab, a sclerostin antagonist, has potential to increase bone formation (anabolic) and decrease bone resorption (anti-catabolic) in persons with chronic SCI. Conventional anti-resorptive therapy alone would not be anticipated to reverse sublesional bone loss in a timely manner because the skeleton below the level of lesion in chronic SCI is assumed to be in a low turnover state. However, because there is a high likelihood that the bone accrued while on romosozumab will be lost once discontinued, denosumab, an anti-resorptive agent, will be administered after treatment with romosozumab, to maintain or, possibly, to continue to increase, bone mineral density (BMD). The purpose of this study is to address the gap in the treatment of osteoporosis in individuals with chronic SCI by partially restoring BMD with romosozumab treatment for 12 months and then to maintain, or further increase, BMD with denosumab treatment for 12 months. A two group, randomized, double-blind, placebo-controlled clinical trial will be conducted in 39 participants who have chronic (\>3 years), motor-complete or incomplete SCI and areal BMD (aBMD) values at the distal femur of at the distal femur \<1.0 g/cm2 measured by dual photon X-ray absorptiometry (DXA). The intervention group will receive 12 months of romosozumab followed by 12 months of denosumab, and the control group will receive 12 months of placebo followed by 12 months denosumab.