Actively Recruiting
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
Led by Samsung Medical Center · Updated on 2026-04-24
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Samsung Medical Center
Lead Sponsor
K
Korea Health Industry Development Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness, usability, and safety of home-based upper limb rehabilitation using the Neofect Smart Glove compared with conventional home-based occupational therapy for patients with upper limb dysfunction in the late subacute and chronic stages of neurological diseases such as stroke, traumatic brain injury, and brain tumor. This is a randomized, single-blinded controlled trial focused on patients aged 19 to 85 years with hemiparesis lasting more than 3 months. The study compares two groups: one using the Neofect Smart Glove device and the other performing occupational therapy with a workbook provided by the research team. Each group will complete 20 sessions of home-based upper limb rehabilitation training, with sessions lasting 30 minutes each, conducted once daily, five days per week, over a four-week period. Participants will be assessed before and after the intervention using the Fugl-Meyer assessment to measure upper limb improvement. Researchers will monitor participants' ability to use the smart glove and perform exercises, cognitive function, and spasticity levels. Safety and usability will be observed throughout the study, which is sponsored by Samsung Medical Center and is expected to conclude by the end of 2026.
CONDITIONS
Brief Title
Effect of Untact Upper Extremity Rehabilitation Using Smart Glove for Late Subacute and Chronic Patients With Brain Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with brain disorder aged 19 to 85 years old
- Hemiparesis lasting more than 3 months due to neurological diseases such as stroke, traumatic brain injury, or brain tumor, with impaired upper limb function
- Spasticity of wrist and finger flexors and extensors on affected side with a Modified Ashworth Scale score of 1+ or lower
- Sufficient cognitive function to understand instructions and perform tasks (K-MMSE score of 21 or higher)
You will not qualify if you...
- Pre-existing significant neurogenic disorders
- Major psychiatric disorders such as schizophrenia, bipolar disorder, or dementia
- History of diseases causing pain or muscle atrophy in affected upper limb before neurological disease onset interfering with rehabilitation
- Severe spasticity in affected upper limb (Modified Ashworth Scale score 3 or higher)
- Skin disorders or open wounds on affected upper limb
- Amputation, fractures, or soft tissue diseases or injuries on affected upper limb
- Severe pain interfering with rehabilitation (Numeric Rating Scale greater than 6)
- Inability to maintain seated posture for more than 10 minutes
- Significant visual impairment preventing recognition of screen when using the smart glove
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants undergo home-based upper limb rehabilitation training using either the Neofect Smart Glove or workbook provided by the research team.
20 sessions, 30 minutes per session, 1 session per day, 5 days a week
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
W
Won Hyuk Chang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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