A recent clinical study aims to evaluate the feasibility of a multichannel functional electrical stimulation (FES) device in the rehabilitation of gait impairment among subchronic stroke patients. Backed by prominent sponsors such as TOPMED, Kurage SAS, and others, the trial has been listed on ClinicalTrials.gov but is not yet recruiting as of the publication date.
In this article
- What changed?
- Who is affected?
- Focusing on the device
- FAQ
- Conclusion
- Disclaimer
- Full announcement information
What changed?
This study, listed under ClinicalTrials.gov identifier NCT07211672, proposes the deployment of cutting-edge functional electrical stimulation technology to aid in recovering gait function among stroke patients three months after onset. The research will assess how this multichannel FES device performs from a clinical implementation standpoint, focusing on safety and therapeutic feasibility.
Sponsors involved in the study include established entities such as TOPMED and Kurage SAS, along with research and clinical rehabilitation support through organizations like Natural Sciences and Engineering Research Council, Canada, and Clinique Synapse – Réadaptation & Vie Active.
Who is affected?
The target population consists of individuals who have experienced a stroke within the last three months, leaving them with significant gait impairments or difficulties in ambulation. This timeframe corresponds to patients in the subchronic stroke phase—a critical recovery window where intervention can yield measurable results. Clinicians, rehabilitation specialists, and device manufacturers in the neuromuscular field may find this study particularly relevant.
If successful, the study findings could inform new approaches to personalized neurorehabilitation, benefiting both stroke survivors and healthcare systems with an optimized management of gait-related conditions.
Focusing on the device
What is a Multichannel Functional Electrical Stimulation Device?
Multichannel functional electrical stimulation (FES) devices use controlled electrical impulses to activate specific muscle groups, mimicking natural movement. This advanced form of neuromuscular training has gained traction in rehabilitation settings due to its ability to target multiple muscles simultaneously.
Safety and Performance Parameters
The study seeks to analyze the functional and safety performance of the device among stroke patients under monitored clinical conditions. According to the manufacturers, the intended purpose of the device aligns with assisting neuromuscular recovery by promoting improved gait symmetry and strength.
Regulatory requirements stipulate stringent testing to confirm the device’s safety, efficacy, and reliability. Only with proven outcomes can this device meet the demands of regulatory approval processes such as MDR Annex XIV.
Implications for Future Rehabilitation Technology
Successful integration and clinical validation of this multichannel FES device may inspire future innovations in medical device technology tailored to neurorehabilitation. Healthcare providers and device developers may look to the study outcomes to guide investments and improve patient outcomes post-stroke.
FAQ
1. Is this study currently recruiting patients?
No, the recruitment phase has not yet started according to ClinicalTrials.gov.
2. What organizations are supporting this study?
Sponsorship and support come from TOPMED, Kurage SAS, Natural Sciences and Engineering Research Council, Canada, and Clinique Synapse – Réadaptation & Vie Active.
3. Who might benefit from the study results?
Stroke patients in the subchronic phase, healthcare professionals specializing in rehabilitation, and stakeholders in neurorehabilitation technology development could benefit from the findings.
Conclusion
This study marks an important step in exploring innovative solutions for improving gait recovery in stroke survivors. By addressing critical aspects such as safety, feasibility, and clinical value, it aims to pave the way for advancements in rehabilitation technology.
Stakeholders in the medical device, clinical research, and stroke rehabilitation ecosystems should monitor the progress of this trial closely. As the study begins recruitment and generates findings, its impact on medical device regulations and clinical practices could become significant.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or professional advice regarding medical devices or clinical trials.
Full announcement information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07211672?term=medical+device