Trial results for a study investigating an overground propulsion neuroprosthesis for individuals after Stroke were posted on ClinicalTrials.gov on 2025-10-20, showing a statistically significant increase in paretic propulsion by 1.77 %bw (p=0.001).
Background
Stroke is a leading cause of long-term disability, often resulting in hemiparesis, which significantly impairs walking ability. Restoring walking function is a primary goal in post-stroke rehabilitation. Current approaches may include physical therapy, assistive devices, and various forms of neurorehabilitation. The development of technologies like neuroprostheses that provide adaptive neurostimulation to affected muscles aims to improve gait mechanics and enhance functional recovery, offering new avenues for rehabilitation and improving the quality of life for individuals living with chronic post-stroke deficits.
Trial design
This completed interventional study, identified as Phase NA, enrolled 10 participants with Stroke. The trial evaluated an overground propulsion neuroprosthesis designed to deliver adaptive neurostimulation assistance to the paretic plantarflexors and dorsiflexors. Participants with chronic post-stroke hemiparesis walked both with and without the neuroprosthesis, overground and on a treadmill. The study's objective was to understand the effects of adaptive neurostimulation on clinical and biomechanical measures of walking function to inform future rehabilitation strategies.
Key results
Key results from the neuroprosthesis-assisted walking evaluation, based on mean differences in final values, include:
- For Immediate Change in Walking Speed, one analysis showed a mean difference of 0.03 meters per second (m/s) (95.0% CI: -0.01 to 0.07, t-test, 2 sided, p=0.131). Another analysis for walking speed reported a mean difference of 0.003 meters per second (m/s) (95.0% CI: -0.034 to 0.039, t-test, 2 sided, p=0.874).
- For Immediate Change in Paretic Propulsion, one analysis indicated a mean difference of 1.77 percent bodyweight (%bw) (95.0% CI: 0.99 to 2.56, t-test, 2 sided, p=0.001). A separate analysis for paretic propulsion showed a mean difference of 3.32 percent bodyweight (%bw) (95.0% CI: 0.75 to 5.89, t-test, 2 sided, p=0.017).
- For Immediate Change in Propulsion Symmetry, one analysis reported a mean difference of -0.36 percent (%) (95.0% CI: -1.18 to 0.46, t-test, 2 sided, p=0.345). Another analysis for propulsion symmetry showed a mean difference of -2.13 percent (%) (95.0% CI: -3.9 to -0.36, t-test, 2 sided, p=0.024).
What this means
The trial results suggest that the overground propulsion neuroprosthesis may offer a beneficial effect on walking mechanics for individuals with chronic post-stroke hemiparesis. Specifically, statistically significant increases were observed in paretic propulsion, with mean differences of 1.77 %bw (p=0.001) and 3.32 %bw (p=0.017). Additionally, a statistically significant change in propulsion symmetry was noted, with a mean difference of -2.13% (p=0.024). While changes in walking speed were not statistically significant, the improvements in paretic propulsion and propulsion symmetry indicate that this neuroprosthesis could potentially enhance the quality of gait and contribute to more effective rehabilitation strategies aimed at restoring functional walking ability in stroke patients.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06459401, titled "Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke", were posted on 2025-10-20 on clinicaltrials.gov.