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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-85
SponsorSamsung Medical Center

About this 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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • home-based Neofect Smart Glove
  • home-based occupational therapy

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Samsung Medical Center

Lead sponsor

Korea Health Industry Development Institute

Collaborator