JPRN-jRCT2062190037进行中（未招募）未知
Investigator-initiated trial of NIRS neurorehabilitation system for poststroke gait disturbance. - NIRS-G01
Mihara Masahito0 个研究点目标入组 70 人开始时间: 2020年3月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients aged 20 years or older with written informed consent from the patient to participate in the study
- •2) Patients with gait disturbance due to first clinical episode of cerebral infarction or intraparenchymal hemorrhage
- •3) Patients aged 12 weeks or more but less than 32 weeks after onset at enrollment
- •4) Patients with a Functional Ambulation Category 3-4 at enrollment
- •5) Patients with a Berg Balance Scale <= 50 at enrollment
- •6) Patients who can sit with feet soles on the floor for at least 10 minutes
- •7) Patients who can be stably evaluated by the Berg balance scale and 10 m walking under the use of assistive devices such as an orthosis and a cane
- •8) Patients who can understand verbal instructions and perform tasks adequately
排除标准
- •1) Patients with severe cognitive impairment, a Mini-mental State Examination <= 23
- •2) Patients with severe frontal lobe dysfunction, a Frontal Assessment Battery <= 12
- •3) Patients with severe leg anesthesia, score 1, the patient recognizes movement of the digits but not the correct direction, even at maximal excursion, or less of the position sense (lower extremity) subscale in Stroke Impairment Assessment Set
- •4) Patients with more than 90% stenosis in anterior cerebral artery on the lesion side
- •5) Patients with cortical lesions involving the supplementary motor area
- •6) Patients with a history of cranioplasty
- •7) Patients with homonymous hemianopsia or severe hemispatial neglect (More than 10% deviation in a 50 cm line bisection test)
- •8) Patients with unstable general condition including vital sign
- •9) Patients with severe eyesight deterioration (Binocular visual acuity of 0.05 or less with correction)
- •10) Patients with severe infections
- •11) Patients with skin lesions requiring treatment on the scalp
- •12) pregnant women
- •13) Patients with a score of 11 or higher on Geriatric depression scale 15
- •14) Patients with a history of or complicated with clinically significant neuropsychiatric disorders
- •15) Patients receiving botulinum toxin therapy, robot rehabilitation, BMI rehabilitation, transcranial magnetic stimulation, transcranial electrical stimulation, or transcutaneous functional electrical stimulation within 6 months prior to enrollment
- •16) Patients whose participation in this study is judged to be inappropriate by the investigator
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