I can't for the life of me figure out what this is, Google searches provide nothing. A tiny bit more information here: FDA lists MedRhythms’ InTandem neurorehabilitation system as Class II device
The latest here:
Revolutionizing Stroke Recovery: An Insight into the InTandem Neurorehabilitation System
Understanding the InTandem Neurorehabilitation System
The InTandem neurorehabilitation system is a novel intervention designed to individually assist individuals post-stroke, providing progressive and personalized rehabilitation without requiring real-time input from a clinician. However, it is worth noting that the system does not eliminate the need for a clinician prescriber. The clinicians’ role is to identify suitable candidates and set patient-specific conditions for the system’s use.
An In-depth Look at the InTandem Randomized Controlled Trial
A multi-site, prospective, interventional, 2-arm randomized controlled trial was conducted to assess the safety and efficacy of InTandem. In total, 87 participants were enrolled in this trial. The study was initially designed to detect a change in gait speed, with the primary endpoint being the change in self-selected comfortable walking speed. This metric was measured using the 10-meter walk test.
Participants were randomized to use InTandem or a treatment-matched Active Control. Both groups were required to complete 15 intervention sessions over a span of 5 weeks. The trial faced interruptions due to the COVID-19 PHE, necessitating an interim analysis and adjustment of alpha. The data were analyzed using IBM SPSS Statistics software, assessing safety, treatment effects, and between-group differences. An exploratory time-course of change analysis was also conducted as part of the study.
Key Findings from the Trial
The trial demonstrated that InTandem was associated with a two-fold larger increase in speed and three times more responders compared to the control group. It also affirmed similar safety profiles, with both groups experiencing the same number of adverse events. These results underline the importance of effective walking rehabilitation in the chronic phase of stroke recovery and the need for interventions that can provide safe and effective walking rehabilitation across various care settings, including the home and the community.
The Role of Technology in Neurorehabilitation
The application of technology in the field of neurosciences, specifically in neurosurgical procedures, neuromodulation, neuroprosthetics, and neurorehabilitation, is increasingly being recognized. The integration of Internet of Things with augmented and virtual reality has shown promising results in diagnosing and treating neurological disorders. The InTandem system, which autonomously applies the principles of rhythmic auditory stimulation to improve walking, has shown encouraging results in previous proof of concept studies.
The Future of Neurorehabilitation
The InTandem neurorehabilitation system trial is a significant step towards evaluating the effectiveness of the InTandem system in improving motor function in patients with neurological disorders. The trial aims to assess the impact of the InTandem system on motor function, quality of life, and overall rehabilitation outcomes. The success of this trial could pave the way for more effective and autonomous neurorehabilitation systems in the future, revolutionizing stroke recovery and the way we approach neurorehabilitation.
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