NCT06837324

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

January 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

January 13, 2025

Last Update Submit

April 23, 2026

Conditions

Home Based RehabilitationBrain Disorder

Outcome Measures

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).

    Within 14 days before the intervention, within 2 days after intervention

Study Arms (2)

home-based Neofect Smart Glove

EXPERIMENTAL

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

Device: home-based Neofect Smart Glove

home-based occupational therapy

ACTIVE COMPARATOR

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

Other: home-based occupational therapy

Interventions

home-based Neofect Smart GloveDEVICE

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 Neofect Smart Glove
home-based occupational therapyOTHER

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.

home-based occupational therapy

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Central Study Contacts

Won Hyuk Chang

CONTACT

+82-2-3410-6068wh.chang@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2025

First Posted

February 20, 2025

Study Start

April 11, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

KR(1)