- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07397767
Development of Quantitative Parameter of Upper Extremity Function in Patients With Brain Disorder Using Smart-Board and Smart-Glove.
February 5, 2026 updated by: Won Hyuk Chang, Samsung Medical Center
Development of Quantitative Parameter of Upper Extremity Function in Patients With Brain Disorder Using Smart-Board and Smart-Glove, Single-Center, Prospective Study
The aim of this study is to develop a novel quantitative metric for assessing upper-limb function in patients with neurological disorders.
This will be accomplished by analyzing performance data obtained from a smart board and smart glove system and comparing these data with conventional clinical assessment methods currently used to evaluate upper-limb impairment.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, South Korea
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults aged 19 years or older.
- Patients with upper-limb functional impairment due to neurological conditions such as stroke, cerebral palsy, brain tumor, traumatic brain injury, or Parkinson's disease.
Exclusion Criteria:
- Patients with progressive neurological disorders or those in a state of hemodynamic instability.
- Patients with severe cognitive impairment (MMSE < 10) or significant communication difficulty due to language disorders.
- Any other condition in which the investigator determines that participation in the study is inappropriate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smart Device User
|
Participants will undergo two sessions of upper-limb movement assessment using the smart board and smart glove on the day of the clinical trial.
Simultaneously, video recordings will be obtained using a mobile camera.
These procedures will be used to collect quantitative data on upper-limb movements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
validity
Time Frame: the day of the study procedures
|
To examine the correlation between the primary outcome measure (FM-UE) and the trunk rehabilitation assessment model derived from mobile camera, smart board, and smart glove data.
|
the day of the study procedures
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2024
Primary Completion (Actual)
December 23, 2025
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
January 20, 2026
First Submitted That Met QC Criteria
February 5, 2026
First Posted (Actual)
February 9, 2026
Study Record Updates
Last Update Posted (Actual)
February 9, 2026
Last Update Submitted That Met QC Criteria
February 5, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-11-105
- RS-2023-00248118 (Other Grant/Funding Number: Korea Medical Device Development Fund)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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