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

Not Applicable

Not yet recruiting

• Conditions: Untact Upper Extremity Rehabilitation; Home Based Rehabilitation; Brain Disorder

• Registration Number: NCT06837363
• Lead Sponsor: Samsung Medical Center

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Study Start: 2025-04-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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
• Participants with sufficient cognitive function to understand the instructions from the researcher and the smart board, 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, which is required for using the smart board
• Significant visual impairment to the extent that the screen cannot be recognized when using the smart board

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement of uper limb score in Fugl-Meyer assessment	Within 14 days before the intervention, within 2 days after intervention	(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