MedRhythms has selected Curavit Clinical Research as its virtual contract research organisation (VCRO) for a trial of its neurorehabilitation system, MR-001.
The neurorehabilitation system has been designed to improve walking and ambulation in adults with chronic stroke walking impairments.
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The Outcomes and Health Economics of Stroke using Rhythmic Auditory Stimulation (OrcHESTRAS) trial aims to generate evidence and explore how the product can reduce financial burdens in the US healthcare system.
It intends to further characterise MR-001’s economic and clinical advantages beyond what has already been determined in a multi-centre, randomised clinical study.
Furthermore, the trial will assess patient engagement and therapeutic response durability.
Curavit will manage all aspects of MedRhythms’ hybrid decentralised clinical trial.
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By GlobalDataThe aspects range from the finalisation of protocols and Institutional Review Board approvals to subject recruitment, physical site testing, monitoring of sites and patients remotely, healthcare economics and outcomes analysis.
The 12-month study intends to enrol 225 subjects by the end of this year.
MedRhythms president and co-founder Owen McCarthy said: “Curavit’s tech-enabled approach to research lets us launch quickly while delivering a premier experience for everyone involved.
“As important, the study will be open to participants nearly nationwide, thanks to Curavit’s virtual site solution, patient recruitment process and smart strategies for collecting real-world healthcare economics data.”
MR-001 is based on the Rhythmic Auditory Stimulation clinical approach that leverages the auditory-motor entrainment mechanism.
The brain’s motor and auditory systems subconsciously synchronise to an external auditory cue, such as music, during entrainment.
