JMIR Publications

ABSTRACT

Background:

Persistent walking impairment following a stroke is common. Although rehabilitative interventions exist, few exist for use at home in the chronic phase of stroke recovery. MR-001 (InTandem™) is a neurorehabilitation system intended to improve walking and community ambulation in adults with chronic stroke walking impairment.

Objective:

Using design best practices and human factors engineering principles, the research presented here was conducted to validate the safety and effectiveness of use of InTandem.

Methods:

Fifteen participants in the chronic phase of stroke recovery (≥ six months post-stroke) participated in this validation study. Participants were scored on eight simulated use tasks, four knowledge assessments, and seven comprehension assessments in a simulated home environment. The number and types of use errors, close calls, and operational difficulties were evaluated. Analyses of task performances, participant behaviors, and follow-up interviews were conducted to determine the root cause of use errors, difficulties, and mitigation strategies.

Results:

During this validation study, 93% of participants (14 of 15) were able to successfully complete the critical tasks associated with simulated use of the InTandem system. Following simulated use task assessments, participants' knowledge and comprehension of the IFU and key safety information was evaluated. Overall, participants were able to find and correctly interpret information in the materials in order to answer the knowledge assessment questions. During the comprehension assessment, participants understood warning statements associated with critical tasks presented in the IFU. In total, three use errors were recorded. No adverse events, including slips, trips or falls, occurred in this study.

Conclusions:

In this validation study, people in the chronic phase of stroke recovery were able to safely and effectively use InTandem in the intended setting. This validation study contributes to the overall understanding of residual use-related risks of InTandem, in consideration of the established benefits.