A home based upper limb rehabilitation exercises using a smart glove for patients with brain disorders lasting more than three months..

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010260

Enrollment

Registered

2025-03-06

Start date

2025-03-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : [Experimental group] -home-based upper limb rehabilitation training using the Neofect Smart Glove -a total of 20 sessions of home-based upper limb rehabilitation training using the Ne

Eligibility

Sex/Gender

All

Inclusion criteria

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~2=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

Design outcomes

Primary

Measure	Time frame
Fugl Meyer assessment scale	—

Secondary

Measure	Time frame
Action research arm test;Grip strength;Box and block test;Medical Research Council scale of muscle strength;Active Range of Motion	—

Countries

Korea, Republic of

Contacts

Public ContactWon Hyuk Chang

Samsung Medical Center

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

Outcome results