CClinicalTrials.gg
RecruitingNCT06837324brain disorderUpdated Apr 24, 2026

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

An interventional study of home-based Neofect Smart Glove and home-based occupational therapy in Brain Disorder and Home Based Rehabilitation, sponsored by Samsung Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years to 85 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Brain Disorder
  • Home Based Rehabilitation

Browse trials for

03

In context

Brain Diseases

758 studies on the registry are indexed under Brain Diseases; 202 are open to participants now.

This study's planned enrollment of 40 is below the median of 58 across 454 interventional studies indexed under Brain Diseases.

Browse Brain Diseases studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    home-based Neofect Smart Glove

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

    Device: home-based Neofect Smart Glove

  • Active comparator
    home-based occupational therapy

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

    Other: home-based occupational therapy

Interventions

  • Devicehome-based Neofect Smart Glove

    a total of 20 sessions of home-based upper limb rehabilitation training using the Neofect Smart Glove, with 30 minutes per session, 1 session per day, 5 days a week, for 4 weeks.

  • Otherhome-based occupational therapy

    a total of 20 sessions of home-based upper limb rehabilitation training using the workbook provided by the research team , with 30 minutes per session, 1 session per day, 5 days a week, for 4 weeeks.

06

What researchers measure

Primary outcomes

  1. Improvement of uper limb score in Fugl-Meyer assessment

    The total score ranges from 0 to 66, with higher scores indicating better motor function. This outcome reports the change in score, calculated as: (Score at Post-intervention) minus (Score at Baseline).

    Time frame: Within 14 days before the intervention, within 2 days after intervention

07

Study locations

1 of 1 sites recruiting
  • Samsung Medical Center
    Seoul, South Korea
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06837324
Lead sponsor
Samsung Medical Center
Collaborators
Korea Health Industry Development Institute
Responsible party
Won Hyuk Chang (Professor, Samsung Medical Center) — Principal investigator
First posted
Feb 20, 2025
Start date
Apr 11, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 24, 2026

Study contacts

Won Hyuk Chang
Contact
wh.chang@samsung.com
+82-2-3410-6068

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion