Effect of Untact Upper Extremity Rehabilitation Using a Smart Board for Late Subacute and Chronic Patients With Brain Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-85
SponsorSamsung Medical Center

About this trial

The aim is to clinically validate the clinical efficacy, usability, and safety of home-based upper limb rehabilitation training using the Neofect Smart Board by comparing the effects between a group using the home-based Neofect Smart Board 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with neurological diseases 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 shoulder flexor and adductor muscle strength of MRC grade 2 or higher

Patients with shoulder extensor and abductor spasticity of MAS grade 1+ or lower

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Home-based Neofect Smart board

    Device

    a total of 20 sessions of home-based upper limb rehabilitation training using the Neofect Smart board, with 30 minutes per session, 1 session per day, 5 days a week, for 4 weeeks.

  • home-based occupational therapy

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Home-based Neofect Smart BoardExperimental treatment 1 intervention
Group B: home-based occupational therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improvement of uper limb score in Fugl-Meyer assessment

(upper limb motor score in Fugl-Meyer assessment at post-intervention) - (upper limb motor score in Fugl-Meyer assessment at baseline) Higher scores mean a better outcome

Time frame
Within 14 days before the intervention, within 2 days after intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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