Brain Disorder, Home Based Rehabilitation
Conditions
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.
Interventions
DEVICEhome-based Neofect Smart Glove
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.
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.
Sponsors
Samsung Medical Center
Korea Health Industry Development Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of uper limb score in Fugl-Meyer assessment | Within 14 days before the intervention, within 2 days after intervention | 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). |
Countries
South Korea
Contacts
CONTACTWon Hyuk Chang
Outcome results
None listed