A clinical trial evaluating feasibility and acceptability of a brain-computer interface for telerehabilitation in patients with stroke.

Abstract

Background: We have created a groundbreaking telerehabilitation system known as Tele BCI-FES. This innovative system merges brain-computer interface (BCI) and functional electrical stimulation (FES) technologies to rehabilitate upper limb function following a stroke. Our system pioneers the concept of allowing patients to undergo BCI therapy from the comfort of their homes, while ensuring supervised therapy and real-time adjustment capabilities. In this paper, we introduce our single-arm clinical trial, which evaluates the feasibility and acceptance of this proposed system as a telerehabilitation solution for upper extremity recovery in stroke survivors.

Method: The study involved eight chronic patients with stroke and their caregivers who were recruited to attend nine home-based Tele BCI-FES sessions (three sessions per week) while receiving remote support from the research team. The primary outcomes of this study were recruitment and retention rates, as well as participants perception on the adoption of technology. The secondary outcomes involved assessing improvements in upper extremity function using the Fugl-Meyer Assessment for Upper Extremity (FMA_UE) and the Leeds Arm Spasticity Impact Scale.

Results: Seven chronic patients with stroke completed the home-based Tele BCI-FES sessions, with high retention (87.5%) and recruitment rates (86.7%). Although participants provided mixed feedback on setup ease, they found the system progressively easier to use, and the setup process became more efficient with continued sessions. Participants suggested modifications to enhance user experience. Following the intervention, a significant increase in FMA_UE scores was observed, with an average improvement of 3.83 points (p = 0.032). The observed improvement of 3.83 points in the FMA-UE score approaches the reported Minimal clinically important difference of 4.25 points for patients with chronic stroke.

Conclusion: This study serves as a proof of concept, showcasing the feasibility and acceptability of the proposed Tele BCI-FES system for rehabilitating the upper extremities of stroke survivors. While some participants demonstrated significant improvements in FMA-UE scores, these findings are not generalizable, as they were derived from a small-scale feasibility study. The results should be interpreted cautiously within the study's specific context. Additionally, the intervention was not compared to other therapeutic approaches, limiting conclusions regarding its relative effectiveness. To further validate the efficacy of the proposed Tele BCI-FES system, it is essential to conduct additional research with larger sample sizes and extended rehabilitation sessions. Moreover, future studies should include comparisons with other therapeutic approaches to better evaluate the relative effectiveness of this intervention. Trial registration This clinical study is registered at clinicaltrials.gov https://clinicaltrials.gov/study/NCT05215522 under the study identifier (NCT05215522) and registered with the ISRCTN registry https://doi.org/10.1186/ISRCTN42991002 (ISRCTN42991002).