Trial results for BCI-FES Therapy for Stroke Rehabilitation were posted on ClinicalTrials.gov on 2026-02-10, involving 62 participants with stroke.
Background
Stroke affects over 7 million survivors in the US, with approximately 795,000 new cases each year. A significant portion, 30-60%, experience persistent difficulty walking due to foot weakness, even with existing physiotherapy. New approaches are needed to provide lasting improvements for these post-stroke gait impairments. Brain-computer interface (BCI) technology, which allows direct brain control of external devices, is being explored as a novel method for rehabilitation.
Trial design
This completed study, designated as Phase NA, enrolled 62 participants with conditions including Ischemic Stroke and Hemorrhagic Stroke. The trial investigated BCI-FES Dorsiflexion Therapy with physiotherapy compared to dose- and intensity-matched physiotherapy alone.
Key results
The trial reported several key measurements for both intervention groups:
- Gait Velocity:
- For the BCI-FES Dorsiflexion Therapy With Physiotherapy group, mean gait velocity measurements were 0.38 m/s (Standard Deviation 0.21 m/s) and 0.46 m/s (Standard Deviation 0.23 m/s).
- For the Dose-and Intensity-matched Physiotherapy group, mean gait velocity measurements were 0.38 m/s (Standard Deviation 0.26 m/s) and 0.45 m/s (Standard Deviation 0.34 m/s).
- Dorsiflexion Range of Motion:
- For the BCI-FES Dorsiflexion Therapy With Physiotherapy group, mean dorsiflexion range of motion measurements were -12.54 degrees (Standard Deviation 13.78 degrees) and -10.05 degrees (Standard Deviation 13.07 degrees).
- For the Dose-and Intensity-matched Physiotherapy group, mean dorsiflexion range of motion measurements were -16.67 degrees (Standard Deviation 15.78 degrees) and -13.94 degrees (Standard Deviation 15.74 degrees).
- Gait Endurance (Six Minute Walk Test: 6MWT):
- For the BCI-FES Dorsiflexion Therapy With Physiotherapy group, mean gait endurance measurements were 101.08 m (Standard Deviation 57.16 m) and 118.19 m (Standard Deviation 60.91 m).
- For the Dose-and Intensity-matched Physiotherapy group, mean gait endurance measurements were 105.74 m (Standard Deviation 75.60 m) and 118.83 m (Standard Deviation 85.38 m).
What this means
The posted results provide specific mean measurements for gait velocity, dorsiflexion range of motion, and gait endurance for both the BCI-FES therapy group and the control physiotherapy group. Across these outcomes, the observed mean values and their standard deviations were largely comparable between the two intervention arms. Without further comparative analyses or statistical significance, these data suggest that BCI-FES Dorsiflexion Therapy, when combined with physiotherapy, yielded similar improvements in these specific rehabilitation parameters as dose- and intensity-matched physiotherapy alone in this study population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study "BCI-FES Therapy for Stroke Rehabilitation" were posted on 2026-02-10 on clinicaltrials.gov.