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

NCT04173975 · Casa di Cura Privata del Policlinico SpA · Updated 22 Feb 2022

What is being tested
With knee exoskeleton
For
Knee Instability; Neuromuscular Diseases; Central Nervous System Diseases; Stroke
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 30 years to 85 years. The full rules are on the registry page.
Where
Not stated
When
Starts or started 1 Jan 2021, ends 31 Aug 2021. Registered 22 Nov 2019.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT04173975