A Multicenter Confirmation Clinical Trial of Untact Upper Extremity Rehabilitation Using Smart Glove for Late Subacute and Chronic Patients With Brain Disorder - a Randomized Single-blinded Controlled Trial

What this Trial Is About

Researchers are evaluating the clinical effectiveness, usability, and safety of home-based upper limb rehabilitation using the Neofect Smart Glove compared with conventional home-based occupational therapy for patients with upper limb dysfunction in the late subacute and chronic stages of neurological diseases such as stroke, traumatic brain injury, and brain tumor. This is a randomized, single-blinded controlled trial focused on patients aged 19 to 85 years with hemiparesis lasting more than 3 months. The study compares two groups one using the Neofect Smart Glove device and the other performing occupational therapy with a workbook provided by the research team. Each group will complete 20 sessions of home-based upper limb rehabilitation training, with sessions lasting 30 minutes each, conducted once daily, five days per week, over a four-week period. Participants will be assessed before and after the intervention using the Fugl-Meyer assessment to measure upper limb improvement. Researchers will monitor participants ability to use the smart glove and perform exercises, cognitive function, and spasticity levels. Safety and usability will be observed throughout the study, which is sponsored by Samsung Medical Center and is expected to conclude by the end of 2026.

Effect of Untact Upper Extremity Rehabilitation Using Smart Glove for Late Subacute and Chronic Patients With Brain Disorder