Safety and efficacy of InTandemTM, a neurorehabilitation system to improve walking in chronic stroke

Objective: To evaluate the efficacy and safety of InTandemTM to improve chronic stroke walking impairment and ambulation.

Design: Multi-site, prospective, randomized controlled trial.

Setting: Eight rehabilitation hospitals and research institutions in the United States.

Participants: The trial enrolled 87 adults with chronic stroke. 72 participants were included in the final analysis. Participants were on average 8 years post-stroke and 62 years old. Primary inclusion criteria included ≥50 years old, ≥6 months post-stroke, and comfortable walking speed (CWS) ≥ 0.5m/s and < 0.8 m/s.

Interventions: InTandem or self-directed walking (active control) for 30 minutes, 3x’s per week over 5 weeks. InTandem is a neurorehabilitation system that autonomously delivers an individualized and progressively challenging intervention based on the principles of rhythmic auditory stimulation.

Main Outcome Measures: Improvement in CWS (measured with 10MWT), post-intervention CWS > 0.8 m/s and CWS increase greater than the clinically important difference (MCID) of 0.16 m/s, and safety (measured by the number of adverse events).

Results:  InTandem resulted in a greater increase in CWS (average 22%) relative to active control (average 9%; F(1,49)=6.6, p=0.01). A significant between-group difference in the number of participants who surpassed both the MCID and final walking speed thresholds was found (χ2(1)=6.47, p=0.01, Cramer’s V=0.30). InTandem participants were 3.7x’s more likely to surpass both thresholds. Frequency of adverse events was similar across groups.

Conclusions: There are at least 3.5 million people living with chronic stroke walking impairment, for which there is currently no standard of care in the U.S. The results of the pivotal trial suggest that InTandem can help address this unmet need to improve walking and ambulation in people with chronic stroke.

Key Words: stroke rehabilitation, music, neurological rehabilitation