JPRN-jRCT2032210573进行中（未招募）3 期
Investigator-initiated clinical trial of a wearable cyborg HAL voluntary controlled by bioelectrical signals to verify the effectiveness of growth motor function for motor postural disorders related to standing and walking for pediatric patients with cerebral palsy: A multicenter, randomized, parallel-group comparison study - LIFE-STAGE trial
Marushima Aiki0 个研究点目标入组 45 人开始时间: 2022年1月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
- >= 5age old 至 <= 15age old（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria are eligible. (Inpatient or outpatient is not required)
- •(1) Patients with cerebral palsy, etc.
- •(2) Patients for whom written consent is obtained from a substitute and assent is obtained from the patient himself/herself in writing or orally
- •(3) Patients aged 5 to 15 years at the time of consent
- •(4) Patients with a Gross Motor Function Classification System (GMFCS) level II to III
- •(5) Patients who can walk a distance of 10 meters (walking aids may be used, but not a walker with a seat)
- •(6) Patients who have not undergone any lower limb surgery within one year
- •(7) Patients who are able to wear this device
- •Height should be within 100 to 150 cm. However, patients can wear the device even if their height is not within this range, as long as their body sizes, such as thigh length, lower leg length, and waist width, match. Even if the height is within the range, if the body does not fit the size, HAL (size S) may be worn.
- •Weight should be within 15 to 50 kg
排除标准
- •Subjects who do not meet any of the following criteria will be excluded and will not be eligible for this study
- •(1) Patients who present motor postural disorder due to progressive disease or lesion
- •(2) Patients who have had a bioelectrical-driven device (e.g. non-medical HAL for well-being model) within 1 year, or have had the same device 6 times or more even if more than 1 year has passed
- •(3) Patients who have difficulty in voluntary limb movement according to instructions due to impaired consciousness or severe intellectual disability
- •(4) Patients with serious hepatic, renal, cardiovascular, or respiratory disorders (to be determined with reference to Grade 3 in the Criteria for Classification of Severity of Adverse Reactions to Drugs and Other Products, Drug Safety No. 80, Notification of the Director of the Safety Division, Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare)
- •(5) Patients with malignant tumors that have not been cured
- •(6) Patients who cannot put the bioelectrode of this device due to skin diseases, etc
- •(7) Patients with bleeding tendency, osteoporosis, or other complications that may cause problems in standing and walking exercises
- •(8) Patients who are pregnant or who may be pregnant. Also, patients who wish to become pregnant during the study period
- •(9) Patients who have participated in other clinical trials within 6 months prior to enrollment
- •(10) Patients who are unable to operate the device in the cybernic voluntary control (CVC) mode at either the hip or knee joint
- •(11) Patients whose operation of an active medical device or electronic device (e.g. pacemaker) implanted in the body is affected by HAL operation
- •(12) Other patients who are judged by the investigator or sub-investigator to be inappropriate to participate in this study
研究者
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