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

April 23, 2026 updated by: Won Hyuk Chang, Samsung Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Experimental: home-based Neofect Smart Glove
home-based upper limb rehabilitation training using the Neofect Smart Glove
Device: home-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 14 days before the intervention, within 2 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Korea Health Industry Development Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-09-104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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