Effect of Untact Upper Extremity Rehabilitation Using Smart Glove for Late Subacute and Chronic Patients With Brain Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: home-based Neofect Smart Glove, home-based occupational therapy.
- Who it may be relevant to
- Registry conditions: Brain Disorder, Home Based Rehabilitation. Basic parameters: 19 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Device home-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. - Other home-based occupational therapy
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.
Primary outcome measures
- Improvement of uper limb score in Fugl-Meyer assessment [Time frame: Within 14 days before the intervention, within 2 days after intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT06837324 · 2024-09-104