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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement of uper limb score in Fugl-Meyer assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
home-based Neofect Smart Glove
home-based upper limb rehabilitation training using the Neofect Smart Glove
干预措施: home-based Neofect Smart Glove (Device)
home-based occupational therapy
home-based upper limb rehabilitation training using the workbook provided by the research team
干预措施: home-based occupational therapy (Other)
结局指标
主要结局
Improvement of uper limb score in Fugl-Meyer assessment
时间窗: 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).
Improvement of uper limb score in Fugl-Meyer assessment
时间窗: 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).
次要结局
未报告次要终点
研究者
Won Hyuk Chang
Professor
Samsung Medical Center