An early feasibility study for neurological devices: The ARCTRAN study.

INTRODUCTION

An Early Feasibility Study (EFS) is an exploratory clinical investigation of a device to optimize its design through iterative feedback loops during early clinical experience. The ARCTRAN study is an EFS aimed at analyzing efficacy, safety and adherence to the home-rehabilitation device-based (ARC Intellicare) program compared to a paper-based exercise protocol in patients with Parkinson's disease (PD), Multiple Sclerosis (MS) and stroke.

MATERIALS AND METHODS

At baseline (T0), patients of each group were randomly divided into two arms, with a 1:1 ratio: an 'interventional' group received ARC Intellicare and a 'control' group received a paper-based rehabilitation protocol, both consisting of three 60-minute sessions/week for 8 weeks. Each patient was evaluated by means of clinical scales, gait analysis and stabilometry at baseline (T0) and after the rehabilitation (T2).

RESULTS

All patients (n = 90, 30 per group) showed a significant improvement in clinical scales between T0 and T2. Stroke patients showed a bigger gait improvement in the ARC Intellicare arm, measured both by clinical scales (Tinetti gait p = 0.01) and gait analysis parameters. In PD group, only gait analysis parameters recorded a significant improvement in the active arm.

DISCUSSION

We demonstrate the safety of ARC Intellicare for home-based rehabilitation in patients with chronic neurological conditions, with high adherence levels. Moreover, in stroke group, it produced more significant improvements of gait compared to paper-based protocol. In the global scenario of the EFS projects promoted by the Italian Ministry of Health, this study is a starting point to conduct this type of studies in Italy.