Home-based smart glove therapy to improve arm movement after brain injury

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

This test tries the Neofect smart glove at home to see if it improves arm function more than usual home occupational therapy for adults (19–85) with late subacute or chronic arm weakness from brain injury.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 19 Years to 85 Years
• Sex: All
• Sponsor: Samsung Medical Center (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT06837324 on ClinicalTrials.gov

What this trial studies

The trial compares home-based upper limb rehabilitation using the Neofect Smart Glove with conventional home-based occupational therapy in adults who have persistent hemiparesis more than three months after neurological injury. Participants must have mild spasticity (MAS ≤1+) and sufficient cognition (K-MMSE ≥21) to follow device instructions and therapy tasks. Outcomes include measures of clinical efficacy on upper limb function, device usability, and safety during home use. All therapy is delivered in the home setting with enrollment and any required assessments conducted through Samsung Medical Center in Seoul.

Who should consider this trial

Good fit: Adults aged 19–85 with hemiparesis lasting more than three months from stroke, traumatic brain injury, or brain tumor who have impaired upper limb function, MAS ≤1+, and K-MMSE ≥21 are ideal candidates.

Not a fit: Patients with severe spasticity (MAS ≥3), major psychiatric or pre-existing significant neurogenic disorders, open skin wounds on the affected limb, prior limb conditions that limit rehab, or insufficient cognitive function (K-MMSE <21) are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could increase access to engaging, at-home upper limb rehabilitation and lead to measurable improvements in arm function.

How similar studies have performed: Previous research on robotic and sensor-based home rehabilitation devices has shown promising but variable improvements in post-stroke arm function, with larger confirmatory trials still limited.

Eligibility criteria

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

Where this trial is running

Seoul

• Samsung Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Won Hyuk Chang

Conditions: Brain Disorder, Home Based Rehabilitation