On November 12, 2025, clinical and regulatory teams were made aware of a pilot randomized controlled trial (RCT) exploring advanced rehabilitation methods for non-ambulatory chronic stroke survivors. Sponsored by the University of Kansas Medical Center, the study investigates the potential of combining robot-assisted gait training (RAGT) with transcutaneous spinal cord stimulation (tSCS) compared to RAGT alone.
What changed?
This upcoming trial represents a significant step forward in stroke rehabilitation research. It will assess whether combining robot-assisted gait training—a method that enables patients to move their legs in a walking motion—and transcutaneous spinal cord stimulation—an intervention stimulating the spinal cord via electrodes placed on the skin—delivers superior improvements in mobility among chronic stroke patients who are non-ambulatory.
What are the study details?
Key Conditions
The trial focuses exclusively on chronic stroke patients who are unable to walk independently. This population often faces limited recovery options beyond traditional physical therapy.
Intervention Groups
Participants will be randomized into two groups:
- Group 1: Robot-assisted gait training combined with transcutaneous spinal cord stimulation.
- Group 2: Robot-assisted gait training alone.
The study will compare these groups to evaluate whether tSCS enhances walking-related neural recovery and functional outcomes.
Sponsorship
The trial is sponsored by the University of Kansas Medical Center, which has previously led initiatives in stroke rehabilitation advancements.
Status
The clinical trial is not yet recruiting. Stakeholders are encouraged to monitor recruitment updates via ClinicalTrials.gov.
Why is this study important?
Stroke survivors with persistent loss of motor function face significant quality-of-life challenges. Innovations in medical devices like robotic gait trainers combined with adjunct therapies such as spinal cord stimulation could redefine rehabilitation outcomes for this demographic.
Addressing Unmet Needs
The study addresses a critical unmet need in chronic stroke recovery, targeting patients for whom traditional rehabilitation methods have been insufficient. If successful, it could pave the way for wider adoption of tSCS-enhanced robotics in clinical practice.
Does this align with FDA focus?
The trial aligns with the U.S. FDA’s emphasis on promoting innovative medical devices that enhance patient outcomes. Such studies establish evidence required for regulatory evaluation and potential market adoption.
FAQ
- What are RAGT and tSCS?
Robot-assisted gait training replicates walking movements using a mechanical device, while transcutaneous spinal cord stimulation uses electrical impulses to activate spinal cord nerves. - Who is eligible?
Chronic stroke patients who cannot walk independently. Specific inclusion and exclusion criteria will be defined in study recruitment materials. - Where will the trial take place?
At institutions affiliated with the University of Kansas Medical Center.
Conclusion
This study could deliver a new therapeutic option for stroke survivors facing long-term immobility. Clinical, quality, and regulatory teams should stay informed about recruitment timelines and initial outcomes.
Disclaimer
This content is informational and intended for professional audiences. It does not constitute regulatory, clinical, or legal advice.
Further information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07226518?term=medical+device