A new clinical study uses TecnoBody ProKin Posturometry and 3D motion analysis to assess trunk control and postural stability in patients with stroke Parkinson disease and multiple sclerosis. The work is led at Somogy Megyei Kaposi Mor Teaching Hospital and enrolls by invitation. The interventions revolve around device enabled posturography and motion capture to generate objective data that may inform rehabilitation decisions and device performance assessments. This article summarizes what changed, who is affected, and why the study matters to regulators, clinicians and device developers.
What is studied?
The project is described as an assessment of trunk control and postural instability in people with neurological disorders. The aim is to use objective measurement tools to quantify postural performance rather than rely on subjective observation. The study involves three parallel device groups targeting each condition with the same measurement framework. This approach supports comparability across conditions while evaluating the performance of the selected technologies in a clinical setting.
What tools are used?
Measurement is conducted with TecnoBody ProKin Posturometry and a 3D motion analysis system. ProKin Posturometry provides trunk related data and postural metrics that can be tracked over time. The 3D motion analysis component offers detailed kinematic information about body segments during controlled tasks. Together these tools generate quantitative endpoints that may support rehabilitation planning and device evaluation. The sponsoring institution indicates that device based posturography and motion capture will be used in three cohorts representing the target conditions.
Which conditions are included?
Participants include individuals diagnosed with stroke, Parkinson disease and multiple sclerosis. The trial design aligns each condition with an identical evaluation protocol to obtain comparable metrics across groups. Enrolling by invitation suggests selective recruitment through clinical sites associated with the sponsor. The report notes the involvement of a specific hospital and the device oriented design of the interventions rather than a purely pharmacologic or purely therapeutic approach.
What is the regulatory context and sponsor details?
The study aligns with regulatory science aims by using objective measurement to support device performance and safety claims. The sponsor listed is Somogy Megyei Kaposi Mor Teaching Hospital. Interventions are described as Device: Stroke posturo/3D group, Device: Parkinson posturo/3D group, Device: Multiple sclerosis posturo/3D group. The description indicates an intent to generate evidence on real world application of the posturography and motion analysis platform across conditions. While no results are reported, the setup highlights the potential for standardized data to inform intended use statements and performance characteristics under regulatory review. The source cites a ClinicalTrials.gov record and a public listing for transparency and tracking.
What are next steps and implications for clinicians and regulators?
If the data demonstrate consistent and clinically meaningful improvements in quantifiable trunk control or in the stability profile across the studied conditions, the findings may influence rehabilitation workflows and device evaluation criteria. Regulators may look for robust measurement properties such as reliability, validity and responsiveness of the TecnoBody ProKin Posturometry system and the accompanying 3D motion analysis platform. For clinicians, the study may offer a framework for integrating objective posture metrics into treatment planning. For device developers, the project underscores the value of standardized endpoints and cross condition comparability in posturography based assessments.
FAQ
- 1. What conditions are included in the study? Stroke, Parkinson disease and multiple sclerosis are specified in the study description.
- 2. What devices are used to collect data? TecnoBody ProKin Posturometry and a 3D motion analysis system are employed to gather trunk and movement data.
- 3. How can participants enroll? Enrollment is by invitation, as indicated by the study listing.
- 4. Who funds and conducts the study? The sponsor is Somogy Megyei Kaposi Mor Teaching Hospital and the study is organized around device driven evaluation groups.
Conclusion
Disclaimer
This content is for professional informational purposes and does not constitute legal advice. It reflects a summary of a study listing and does not replace regulatory filings or guidance.
Announcement reference
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07411664?term=medical+device