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

Samsung Medical Center

Status: Enrolling

Conditions: Home Based Rehabilitation; Brain Disorder

Treatments: Device: home-based Neofect Smart Glove; Other: home-based occupational therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06837324

2024-09-104

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

home-based Neofect Smart Glove

Experimental group

Description:

home-based upper limb rehabilitation training using the Neofect Smart Glove

Treatment:

Device: home-based Neofect Smart Glove

home-based occupational therapy

Active Comparator group

Description:

home-based upper limb rehabilitation training using the workbook provided by the research team

Treatment:

Other: home-based occupational therapy