This report covers a Samsung Medical Center device study testing a smart board and smart glove to measure upper limb function in brain disorder patients under regulatory oversight.
Publication date context February 20 2026 is noted in this report. The study aims to develop a quantitative parameter of upper extremity function in patients with a brain disorder by using a smart board and a smart glove. The trial is listed on ClinicalTrials.gov with the identifier NCT07397767 and is described as Active, not recruiting. The sponsor is Samsung Medical Center and the intervention is described as a device based rehabilitation approach using smart hardware.
What is this study?
The objective is to develop a quantitative parameter for upper extremity function in brain disorder patients using a smart board and smart glove. The study uses a device based rehabilitation approach and is sponsored by Samsung Medical Center. The clinical trial registry shows the identifier NCT07397767 and indicates the study status as Active, not recruiting.
Study design and population
Details on inclusion criteria and sample size are not provided in the source. The emphasis is on creating objective measurement data during rehabilitation sessions rather than subjective observation.
What devices are used?
Participants use a smart board and a smart glove as the core hardware for data collection during arm function tasks. The goal is to derive a quantitative parameter from these devices that reflects upper limb performance in brain disorder settings. The source frames this as a rehabilitation device study involving a hardware based solution.
Data collection and metrics
Exact metrics and data collection protocols are not specified. The intention is to capture objective measures that could support future analysis and device development.
Who funds this work and what regulatory context applies?
Samsung Medical Center is listed as the sponsor. The project appears in ClinicalTrials.gov with the identifier NCT07397767 and status Active, not recruiting. The source does not indicate formal regulatory approvals or CE marking. Registry information is intended to inform on study scope and sponsor intent rather than provide device clearance.
Regulatory framing
Statements about intended use and safety are descriptive and not treated as regulatory clearance. The MDR style approach would present the information as a basis for future regulatory submissions if results support it.
What is the status and what safety considerations are noted?
The ClinicalTrials.gov entry lists the study as Active, not recruiting. No safety outcomes or adverse event data are provided in the source. As with any device based rehabilitation research, standard risk assessment and safety monitoring would apply in line with regulatory expectations when results are shared.
Enrollment timeline
Specific enrollment numbers or schedules are not provided. The absence of recruitment details suggests readers should monitor the registry for updates.
What are the implications for practice and research?
Should the study yield validated quantitative measures, clinicians could have objective tools to assess upper extremity function in brain disorder patients. The combination of a smart board and smart glove may guide rehabilitation strategy development and inform future device improvements and trial designs. The information currently available is limited to registry listings and sponsor statements rather than clinical outcome results.
Path to validation
Future publications would need to present validation methods and safety analyses before any clinical use beyond a research setting could be recommended.
FAQ
- 1. What is the purpose of this study
The study aims to develop a quantitative parameter of upper extremity function in brain disorder patients using a smart board and smart glove
- 2. Who sponsors the work
The sponsor listed is Samsung Medical Center
- 3. What is the status of the trial
According to ClinicalTrials.gov the status is Active, not recruiting
- 4. Where can I find more information
Details are available on ClinicalTrials.gov under identifier NCT07397767
- 5. Are these devices approved for clinical use
The source text does not indicate regulatory approval; this is a research activity and may require formal regulatory submissions
Conclusion
The material reviewed indicates a device based study aimed at quantifying upper limb function in brain disorder patients using a smart board and smart glove. The sponsor is Samsung Medical Center, and the registry shows an active but not recruiting status. Regulatory clearance details are not provided in the source.
Disclaimer
This information is intended for professionals and reflects a regulatory style interpretation based on the source text. It is not legal advice.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07397767?term=medical+device