Multi-center randomized controlled trial achieved primary endpoint: Use of InTandem resulted in a clinically-meaningful and statistically-significant increase in walking speed.
Participants randomized to InTandem were three times more likely to be responders as compared to an active control.
Safe and effective home-use was confirmed in a summative usability study.
PORTLAND, Maine, Feb. 8, 2024 /PRNewswire/ -- MedRhythms announced today publication of two studies validating the efficacy, safety, and usability of InTandem™, a FDA-authorized, prescription-only neurorehabilitation system for home use to improve walking and ambulation in adults with chronic stroke. Results of the multi-site randomized controlled trial demonstrated the clinical benefits and safety of InTandem, and were published in Nature Communications. The summative usability study, results of which were published in JMIR Rehabilitation and Assistive Technologies, confirmed the safe and effective use of InTandem by people with chronic stroke in the home environment. InTandem™ includes shoe-worn sensors, a headset, and a touchscreen control unit.