Home-based upper limb rehabilitation with the Neofect Smart Board for late subacute and chronic brain disorder patients
A Multicenter Confirmation Clinical Trial of Untact Upper Extremity Rehabilitation Using Smart Board for Late Subacute and Chronic Patients With Brain Disorder - a Randomized Single-blinded Controlled Trial
This trial will test whether home-based arm exercises using the Neofect Smart Board help adults (19–85) with lasting arm weakness from stroke, traumatic brain injury, or brain tumor more than conventional home occupational therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 19 Years to 85 Years |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06837363 on ClinicalTrials.gov |
What this trial studies
Adults with late subacute or chronic hemiparesis and sufficient cognitive function will be assigned to use the Neofect Smart Board at home or to perform conventional home-based occupational therapy, and their outcomes will be compared. The study will measure clinical efficacy on upper limb function, usability of the smart board, and safety events. Training is performed at home with study oversight and planned outcome assessments at the clinical site. The protocol targets patients with mild-to-moderate shoulder strength and limited spasticity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19–85 with hemiparesis lasting more than three months from stroke, traumatic brain injury, or brain tumor, who have shoulder flexor/adductor strength ≥ MRC grade 2, limited spasticity (MAS ≤ 1+ for extensors/abductors), and K-MMSE ≥ 21.
Not a fit: Patients with severe spasticity (MAS ≥ 3), major psychiatric or neurodegenerative disorders, prior upper-limb disease limiting rehab, significant cognitive impairment, or skin conditions that prevent device use are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could improve arm function and independence while letting patients do guided rehabilitation at home.
How similar studies have performed: Technology-assisted and home-based upper limb rehabilitation approaches have shown promising results in prior trials, though device-specific evidence for the Neofect Smart Board is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with neurological diseases 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 shoulder flexor and adductor muscle strength of MRC grade 2 or higher * Patients with shoulder extensor and abductor spasticity of MAS grade 1+ or lower * Participants with sufficient cognitive function to understand the instructions from the researcher and the smart board, 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, which is required for using the smart board * Significant visual impairment to the extent that the screen cannot be recognized when using the smart board
Where this trial is running
Seoul
- Samsung medical center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Won Hyuk Chang
- Email: wh.chang@samsung.com
- Phone: +82-2-3410-6889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.