The ReHand-BCI trial: a randomized controlled trial of a brain-computer interface for upper extremity stroke neurorehabilitation
Abstract
Background Brain-computer interfaces (BCI) are a promising complementary therapy for stroke rehabilitation due to the close-loop feedback that can be provided with these systems, but more evidence is needed regarding their clinical and neuroplasticity effects. Methods A randomized controlled trial was performed using the ReHand-BCI system that provides feedback with a robotic hand orthosis. The experimental group (EG) used the ReHand-BCI, while sham-BCI was given to the control group (CG). Both groups performed 30 therapy sessions, with primary outcomes being the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) and the Action Research Arm Test (ARAT). Secondary outcomes were hemispheric dominance, measured with electroencephalography and functional magnetic resonance imaging, white matter integrity via diffusion tensor imaging, and corticospinal tract integrity and excitability, measured with transcranial magnetic stimulation. Results At post-treatment, patients in both groups had significantly different FMA-UE scores (EG: baseline = 24.5[20, 36], post-treatment 28[23, 43], CG: baseline = 26[16, 37.5], post-treatment = 34[17.3, 46.5]), while only the EG had significantly different ARAT scores at post-treatment (EG: baseline = 8.5[5, 26], post-treatment = 20[7, 36], CG: baseline = 3[1.8, 30.5], post-treatment = 15[2.5, 40.8]). In addition, across the intervention, the EG showed trends of more pronounced ipsilesional cortical activity and higher ipsilesional…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials
- Tocilizumab in patients with severe COVID-19: a retrospective cohort study
- A new aging measure captures morbidity and mortality risk across diverse subpopulations from NHANES IV: A cohort study
- Fruit, vegetable, and legume intake, and cardiovascular disease and deaths in 18 countries (PURE): a prospective cohort study
- Are noise and air pollution related to the incidence of dementia? A cohort study in London, England
- Long COVID symptoms and duration in SARS-CoV-2 positive children — a nationwide cohort study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.