Knee Instability clinical trials

Validation of the Efficacy and Usability of the BELK Orthosis Knee Module in a Neurological Setting (BELK@CCP)

This present study will be devoted to the first clinical study on the efficacy of the BELK system in enhancing mobility and improve the knee rehabilitation process in people with NeuroMuscular Diseases (NMD) and Central Nervous System (CNS) disorders with knee instability that implies deficit in gait and in locomotion during ADL. Participants will receive a 6-week training program (3 weeks with the BELK orthosis knee module) in a clinical setting in add-on to the standard neuro-rehabilitation treatment. Gait analysis and Instrumental Test will be performed every week till the end of the six-week training period while the Clinical Scales and Questionnaires will be performed after three weeks and at the end of the training period. Finally, additional outcome measures comprise the scores on the System Usability Scale (SUS) to evaluate the hardware and the Software Usability Measurement Inventory (SUMI) to evaluate the software of the BELK orthosis. These two measures will be administrated at the end of training with Belk orthosis, to rate patients' and operators' (e.g., physical therapist, medical doctors) satisfaction. During 2018, the company GOGOA (www.gogoa.eu), specialized in design, manufacturing and commercialization of Robotic Assisted Rehabilitation (RAR) systems, has developed a first prototype of the BELK system, a powered wearable robotic device that can be used for knee rehabilitation, in the sub-acute phase of knee injuries. As BELK is a wearable device, it can be used both, by the physiotherapist in the rehabilitation centers, improving the knee rehabilitation process and increasing patients' comfort, and accelerating their rehabilitation process. Casa di Cura del Policlinico (CCP https://www.ccppdezza.it/en/) is a fully integrated multi-specialty clinical center aiming at providing both inpatient and outpatient services mainly directed to neurological patients. The Center is constituted as a Department of Neuro-rehabilitation Sciences, accredited by the Italian National Health System, and economically supported by Regione Lombardia. CCP offers to chronic neurological patients the highest comprehensive standards of care in a comfortable environment, through a multidisciplinary patient management approach organized around a core rehabilitation program.