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Recruiting Not applicable NCT06837324

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

No applicable phase (e.g. observational)
Conditions: Brain Disorder Home Based Rehabilitation

Sponsor: Samsung Medical Center

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
home-based Neofect Smart Glove
DEVICE
home-based occupational therapy
OTHER
Locations 1
South Korea (1)
Samsung Medical Center
Seoul
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
19 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
11.04.2025
Completion date
31.12.2026
Registry ID
NCT06837324
Source
clinicaltrials.gov
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