Multi-center observational study and present status survey for the establishment of the standard method for the long-term use of HAL. - NCY extended03

Takashi Nakajima0 个研究点目标入组 200 人开始时间: 2019年8月2日最近更新: 2023年10月17日

试验速览

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•(1) Patients for whom at least one course of treatment using HAL was performed, and the conditions before and after the course were evaluated, or such a course and evaluation are planned
•(2) Patients who can opt out using consent written by themselves or using a prescribed method.Patients who can provide his/her own written consent. For patients aged 16 or older and under 20, informed consent by legal guardian is required in addition to him/her consent. For patients under 16, obtaining informed assent by him/her is encouraged after explaining the study in readily comprehensible language. If the patient has sufficient ability to consent but has difficulty writing due to primary disease progression, written consent is to be obtained from the patient's legally acceptable representative after confirming that the subject himself/herself consents to participate in the study;

•(1)In the case that patient's length and shape are not fit to HAL(Lower Limb Type).
•(2)In the case that patient is not allowed to stand and/or walk with HAL(Lower Limb Type).
•(3)In the case that electrodes are not allowed to be put on the patient's skin because of the patient's skin disease.
•(4)Ineligibility for participating in this study according to the investigator or subinvestigator.
•The above (1)-(3) correspond to contraindications/prohibitions for HAL for medical use (lower limb-type).

发起方