Trial results for a study investigating Powered Orthotic Exoskeleton Training in Stroke were posted on ClinicalTrials.gov on 2025-06-10. The study, which enrolled 22 participants, reported a statistically significant within-group improvement in the Five Times Sit to Stand Test for the exoskeleton training group (p=0.007).
Background
Stroke is a leading cause of long-term disability, frequently resulting in impaired walking ability, reduced independence, and a diminished quality of life. These gait disturbances, coupled with decreased physical activity, often lead to reduced muscle strength in the affected leg and cardiovascular deconditioning. Addressing mobility limitations is crucial for stroke survivors. The study explored the use of a novel battery-powered device, the Keeogo powered orthotic exoskeleton, which assists knee movement during walking, sitting, and standing by monitoring hip movement, aiming to improve functional mobility.
Trial design
This completed study, designated as Phase NA, enrolled 22 participants with Stroke. The trial investigated the effects of Powered Orthotic Exoskeleton Training. Participants were divided into a Powered Orthotic Exoskeleton Training Group and a Control Group. The study assessed various functional mobility outcomes, including the Five Times Sit to Stand Test (5xSTS), Six Minute Walk Test (6MWT), Ten Meter Walk Test (10MWT), and Timed Up and Go (TUG) Test.
Key results
Key measurements and analyses from the trial include:
- Five Times Sit to Stand Test (5xSTS):
- For the Powered Orthotic Exoskeleton Training Group, the mean change from baseline was -20.3 seconds (Standard Deviation 14.2 seconds) when assessed while not wearing the Powered Exoskeleton. A within-group ANOVA analysis showed a p-value of 0.007 for this change.
- The Control Group showed a mean change from baseline of -10.9 seconds (Standard Deviation 16.9 seconds) when assessed while not wearing the Powered Exoskeleton. A within-group ANOVA analysis showed a p-value of 0.24 for this change.
- When assessed while wearing the Powered Exoskeleton, the training group had a mean change from baseline of -9.3 seconds (Standard Deviation 5.3 seconds). A within-group t-test showed a p-value of 0.04 for this change.
- Six Minute Walk Test (6MWT):
- The Powered Orthotic Exoskeleton Training Group had a mean change from baseline of 59.8 meters (Standard Deviation 102.4 meters) when assessed while not wearing the Powered Exoskeleton. A within-group ANOVA analysis showed a p-value of 0.129 for this change.
- The Control Group showed a mean change from baseline of 67 meters (Standard Deviation 59.4 meters) when assessed while not wearing the Powered Exoskeleton. A within-group ANOVA analysis showed a p-value of 0.25 for this change.
- When assessed while wearing the Powered Exoskeleton, the training group had a mean change from baseline of 57.8 meters (Standard Deviation 70.4 meters). A within-group t-test showed a p-value of 0.073 for this change.
- Ten Meter Walk Test (10MWT):
- The Powered Orthotic Exoskeleton Training Group showed a mean change from baseline of 0.24 meters/second (Standard Deviation 0.34 meters/second).
- The Control Group showed a mean change from baseline of 0.19 meters/second (Standard Deviation 0.16 meters/second).
- When assessed while wearing the Powered Exoskeleton, the training group had a mean change from baseline of 0.17 meters/second (Standard Deviation 0.18 meters/second).
- Timed Up and Go (TUG) Test:
- The Powered Orthotic Exoskeleton Training Group had a mean change from baseline of -5.9 seconds (Standard Deviation 7.9 seconds).
- The Control Group showed a mean change from baseline of -3.3 seconds (Standard Deviation 4.9 seconds).
- When assessed while wearing the Powered Exoskeleton, the training group had a mean change from baseline of -6.7 seconds (Standard Deviation 9 seconds).
What this means
The results indicate that powered orthotic exoskeleton training may offer significant benefits for stroke patients in improving sit-to-stand functional mobility. The statistically significant within-group improvements observed in the Five Times Sit to Stand Test (p=0.007 when not wearing the device, and p=0.04 when wearing it) suggest that this training can enhance a crucial aspect of daily living activities. While other mobility measures like the Six Minute Walk Test, Ten Meter Walk Test, and Timed Up and Go Test showed numerical changes, these did not reach statistical significance in the within-group analyses (p>0.05). These findings highlight the potential of exoskeleton-assisted therapy to improve specific functional tasks for stroke survivors, warranting further investigation in larger trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04241848, titled "Powered Orthotic Exoskeleton Training in Stroke", were posted on 2025-06-10 on clinicaltrials.gov.