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
Samsung Medical Center
40 participants
Apr 11, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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 Criteria9
- 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
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Interventions
a 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.
a 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.
Locations(1)
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NCT06837324