๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ21)
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 โฅ3)
* 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
๐
What it tests
- home-based Neofect Smart Glove
- home-based occupational therapy
Samsung Medical Center
Seoul, South Korea
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.