Validating the Safe and Effective Use of a Neurorehabilitation System (InTandem) to Improve Walking in the Chronic Stroke Population: Usability Study.

Only 15 participants were tested, and all could safely complete a 5- to 7-minute walk, so this does not show safe use for people who cannot walk that distance. The study was a simulated home laboratory session, not real home use, and the walk lasted 5 minutes rather than 30-minute real-world sessions. It did not assess treatment effect or walking outcomes, so it cannot be used as evidence that InTandem improves walking. Noncritical tasks were not scored, so usability problems outside the critical tasks may have been missed. Gait impairment was not a screening criterion, though 87% (13/15) had walking impairment, so the sample was not guaranteed to match the intended population. One participant had a caregiver present, although the device was designed for independent use. No participants had less than a high school education, and no participants had hearing impairment, severe aphasia, speech disorder, lower limb prosthetic, or other neurologic injury, so it says little about those groups. Racial and ethnic diversity was not captured.

MedRhythms, the company developing InTandem, employed authors and funded manuscript preparation. Two authors are MedRhythms employees and hold equity. The testing firm Bold Insight employed authors and was selected to provide third-party evaluation, but data were shared with the sponsor. Another firm, EVERSANA Canada, received funding from MedRhythms to prepare portions of the manuscript.

Do not read this as evidence that InTandem improves walking. The study tested whether people could use the device safely in a simulated home setting, and the authors state it did not assess treatment effect.