Hand Focused Upper Extremity Rehabilitation in the Subacute Phase Post-stroke Using Interactive Virtual Environments.

Introduction: Innovative motor therapies have attempted to reduce upper extremity impairment after stroke but have not made substantial improvement as over 50% of people post-stroke continue to have sensorimotor deficits affecting their self-care and participation in daily activities. Intervention studies have focused on the role of increased dosing, however recent studies have indicated that timing of rehabilitation interventions may be as important as dosing and importantly, that dosing and timing interact in mediating effectiveness. This study is designed to empirically test dosing and timing. Methods and Analysis: In this single-blinded, interventional study, subjects will be stratified on two dimensions, impairment level (Fugl-Meyer Upper Extremity Assessment (FM) and presence or absence of Motor Evoked Potentials (MEPs) as follows; (1) Severe, FM score 10-19, MEP+, (2) Severe, FM score 10-19, MEP-, (3) Moderate, FM score 20-49, MEP+, (4) Moderate, FM score 20-49, MEP-. Subjects not eligible for TMS will be assigned to either group 2 (if severe) or group 3 (if moderate). Stratified block randomization will then be used to achieve a balanced assignment. Early Robotic/VR Therapy (EVR) experimental group will receive in-patient usual care therapy plus an extra 10 h of intensive upper extremity therapy focusing on the hand using robotically facilitated rehabilitation interventions presented in virtual environments and initiated 5-30 days post-stroke. Delayed Robotic/VR Therapy (DVR) experimental group will receive the same intervention but initiated 30-60 days post-stroke. Dose-matched usual care group (DMUC) will receive an extra 10 h of usual care initiated 5-30 days post-stroke. Usual Care Group (UC) will receive the usual amount of physical/occupational therapy. Outcomes: There are clinical, neurophysiological, and kinematic/kinetic measures, plus measures of daily arm use and quality of life. Primary outcome is the Action Research Arm Test (ARAT) measured at 4 months post-stroke. Discussion: Outcome measures will be assessed to determine whether there is an early time period in which rehabilitation will be most effective, and whether there is a difference in the recapture of premorbid patterns of movement vs. the development of an efficient, but compensatory movement strategy. Ethical Considerations: The IRBs of New Jersey Institute of Technology, Rutgers University, Northeastern University, and Kessler Foundation reviewed and approved all study protocols. Study was registered in https://ClinicalTrials.gov (NCT03569059) prior to recruitment. Dissemination will include submission to peer-reviewed journals and professional presentations.

Development of the Home based Virtual Rehabilitation System (HoVRS) to remotely deliver an intense and customized upper extremity training.

BACKGROUND: After stroke, sustained hand rehabilitation training is required for continuous improvement and maintenance of distal function. METHODS: In this paper, we present a system designed and implemented in our lab: the Home based Virtual Rehabilitation System (HoVRS). Fifteen subjects with chronic stroke were recruited to test the feasibility of the system as well as to refine the design and training protocol to prepare for a future efficacy study. HoVRS was placed in subjects' homes, and subjects were asked to use the system at least 15 min every weekday for 3 months (12 weeks) with limited technical support and remote clinical monitoring. RESULTS: All subjects completed the study without any adverse events. Subjects on average spent 13.5 h using the system. Clinical and kinematic data were collected pre and post study in the subject's home. Subjects demonstrated a mean increase of 5.2 (SEM = 0.69) on the Upper Extremity Fugl-Meyer Assessment (UEFMA). They also demonstrated improvements in six measurements of hand kinematics. In addition, a combination of these kinematic measures was able to predict a substantial portion of the variability in the subjects' UEFMA score. CONCLUSION: Persons with chronic stroke were able to use the system safely and productively with minimal supervision resulting in measurable improvements in upper extremity function.

Mechanical and biological evaluation of a hydroxyapatite-reinforced scaffold for bone regeneration.

With over 500,000 bone grafting procedures performed annually in the United States, the advancement of bone regeneration technology is at the forefront of medical research. Many tissue-engineered approaches have been explored to develop a viable synthetic bone graft substitute, but a major challenge is achieving a load-bearing graft that appropriately mimics the mechanical properties of native bone. In this study, sintered hydroxyapatite (HAp) was used to structurally reinforce a scaffold and yield mechanical properties comparable to native bone. HAp was packed into a cylindrical framework and processed under varying conditions to maximize its mechanical properties. The resulting HAp columns were further tested in a 6-week degradation study to determine their physical and mechanical response. The cellular response of sintered HAp was determined using a murine preosteoblast cell line, MC3T3-E1. Cell viability and morphology were studied over a one-week period and MC3T3-E1 differentiation was determined by measuring the alkaline phosphatase levels. Finite element analysis was used to determine the columns' geometric configuration and arrangement within our previously developed composite bone scaffold. It was determined that incorporating four cylindrical HAp columns, fabricated under 44 MPa of pressure and sintered at 1200°C for 5 hr, led to load-bearing properties that match the yield strength of native whole bone. These preliminary results indicate that the incorporation of a mechanically enhanced HAp structural support system is a promising step toward developing one of the first load-bearing bone scaffolds that can also support cell proliferation and osteogenic differentiation. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 107A: 732-741, 2019.