About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- home-based Neofect Smart Glove
- home-based occupational therapy
Treatment groups
Sponsors and collaborators
Samsung Medical Center
Lead sponsor
Korea Health Industry Development Institute
Collaborator