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

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

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.

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)
• skin disorders or open wounds on the affected upper limb
• Amputation, fractures, or soft tissue-related diseases or injuries on the affected upper limb
• severe pain that interferes with rehabilitation of the affected upper limb (Numeric Rating Scale > 6)
• Inability to maintain a seated posture for more than 10 minutes
• Significant visual impairment to the extent that the screen cannot be recognized when using the smart glove