Trial results for the NewGait rehabilitation system for Stroke patients were posted on ClinicalTrials.gov on 2025-12-23, indicating no significant difference in key biomechanical outcomes compared to a control group in a study with 20 participants.
Background
Stroke is a leading cause of long-term disability, often resulting in impaired gait and reduced mobility. Rehabilitation plays a critical role in recovery, helping survivors regain function and independence. However, access to continuous, effective, and affordable rehabilitation tools for home use remains a challenge. The development of low-cost, easy-to-use gait-assistive devices is an ongoing area of research, aiming to provide stroke survivors with accessible options to support their recovery outside of clinical settings.
Trial design
The completed study, identified as Phase NA, enrolled 20 participants with Stroke. The trial, titled "NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations)", aimed to modify the NewGait device for stroke survivors based on feedback and then conduct a short-term biomechanical gait study. The study compared the usability and functionality of the NewGait device against a control group, focusing on biomechanical adaptations. Key measurements included gait speed and ankle muscle activation.
Key results
The trial results included measurements for gait speed and ankle muscle activation for both the NewGait and control groups:
- For Gait Speed, the mean values for the NewGait group were 0.90 meters per second (Standard Error: 0.09), 0.88 meters per second (Standard Error: 0.08), and 0.91 meters per second (Standard Error: 0.09).
- For Gait Speed, the mean values for the Control group were 0.92 meters per second (Standard Error: 0.08), 0.87 meters per second (Standard Error: 0.08), and 0.92 meters per second (Standard Error: 0.09).
- For Ankle Muscle Activation, the mean values for the NewGait group were 75.29 percentage of maximum muscle activation (Standard Error: 15.68), 62.41 percentage of maximum muscle activation (Standard Error: 14.61), and 67.77 percentage of maximum muscle activation (Standard Error: 15.26).
- For Ankle Muscle Activation, the mean values for the Control group were 72.98 percentage of maximum muscle activation (Standard Error: 15.68), 66.77 percentage of maximum muscle activation (Standard Error: 15.05), and 75.46 percentage of maximum muscle activation (Standard Error: 15.12).
Statistical analyses using ANOVA yielded the following p-values: 0.894, 0.299, and 0.469.
What this means
The posted trial results indicate that the NewGait rehabilitation system, as evaluated in this biomechanical study, did not demonstrate a statistically significant difference in gait speed or ankle muscle activation compared to the control group. The ANOVA p-values of 0.894, 0.299, and 0.469 suggest that any observed differences in mean values between the NewGait and control groups for these outcomes could be due to chance. For stroke survivors, this implies that while the NewGait device was designed with usability in mind, the current data does not support its superiority over a control intervention for improving these specific biomechanical aspects of gait.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06269367, titled "NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations)", were posted on 2025-12-23 on clinicaltrials.gov.