A clinical trial evaluating feasibility and acceptability of a brain-computer interface for telerehabilitation in patients with stroke
Abstract
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. 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. 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…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 25 participants or records.
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