The aim is to clinically validate the clinical efficacy, usability, and safety of home-based upper limb rehabilitation training using the Neofect Smart Glove by comparing the effects between a group using the home-based Neofect Smart Glove and a group performing conventional home-based occupational therapy in patients with upper limb dysfunction in the late subacute and chronic stages of neurological diseases.
Patients with brain disorder aged 19 to 85 years old
patients with hemiparesis lasting for more than 3 months due to neurological diseases (stroke, traumatic brain injury, brain tumor) and impaired upper limb function
Patients with spasticity of the wrist and finger flexors and extensors on the affected side, with a Modified Ashworth Scale (MAS) score of 1+ or lower
Participants with sufficient cognitive function to understand the instructions from the researcher and the smart glove, and to perform the tasks (K-MMSE ≥21)
pre-existing significant neurogenic disorders
major psychiatric disorders such as schizophrenia, bipolar disorder, or dementia
History of diseases that caused pain or muscle atrophy in the affected upper limb before the onset of the neurological disease, which interfered with rehabilitation
Severe spasticity of the affected upper limb (Modified Ashworth Scale score ≥3)
Parallel
home-based Neofect Smart Glove
Devicea total of 20 sessions of home-based upper limb rehabilitation training using the Neofect Smart Glove, with 30 minutes per session, 1 session per day, 5 days a week, for 4 weeks.
home-based occupational therapy
Other interventiona total of 20 sessions of home-based upper limb rehabilitation training using the workbook provided by the research team , with 30 minutes per session, 1 session per day, 5 days a week, for 4 weeeks.
Improvement of uper limb score in Fugl-Meyer assessment
The total score ranges from 0 to 66, with higher scores indicating better motor function. This outcome reports the change in score, calculated as: (Score at Post-intervention) minus (Score at Baseline).
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Samsung Medical Center
Lead sponsor
Korea Health Industry Development Institute
Collaborator
