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

Launched by SAMSUNG MEDICAL CENTER · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people with brain disorders improve the use of their arms through home-based rehabilitation. Specifically, it is looking at the effectiveness of a device called the Neofect Smart Glove, which is designed to assist with upper limb exercises. The trial will compare the results of patients using this smart glove with those receiving traditional therapy techniques at home. It aims to see how well the glove works, how easy it is to use, and if it is safe for patients.

To take part in this trial, participants need to be between 19 and 85 years old and have experienced weakness in one arm for more than three months due to conditions like stroke or brain injury. They should also be able to understand simple instructions and perform the exercises. Participants will not be allowed if they have severe stiffness in their arms, certain psychiatric disorders, or injuries that would make rehabilitation difficult. If eligible, participants can expect to do exercises at home using the smart glove or traditional therapy methods, helping them regain strength and movement in their affected arm.

Gender

ALL

Eligibility 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 ≥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