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NCT Number: NCT06837324

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

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.

Recruiting

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Key information

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

home-based Neofect Smart Glove

Device

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.

home-based occupational therapy

Other

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.

Primary outcomes

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

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Won Hyuk Chang

CONTACT

[email protected]

+82-2-3410-6068

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Korea Health Industry Development Institute

Registry information

Official study title

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

Acronym: brain disorder

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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