A randomized controlled trial of the lumbar-type of the Wearable Cyborg HAL (Hybrid Assistive Limb) for the safety and efficacy in hemiplegic patients with acute stroke

Matsumaru Yuji0 个研究点目标入组 44 人开始时间: 2023年4月17日最近更新: 2024年4月23日

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•1) Patients who can agree to the document by themselves. (However, if writing is difficult, set a writer)
•2) Patients aged 16 years or older. (If you are under 18 years old, in addition to the signature of the person himself/herself, a signature by a parent or guardian is also needed)
•3) Patients within 2 to 21 days after onset. (The day of stroke onset is treated as day 0)
•4) Patients with Functional Ambulation Category (FAC) from 0 to 2.
•5) Patients with FAC of 4 or more before onset.
•6) Patients who can wear the lumbar-type of HAL. (Height is assumed to be 150 cm-190 cm, but the condition of use is not height, but for patients whose, body size such as thigh length, lower leg length, waist width, etc. fits)

•1) Patients who have difficulty performing voluntary limb movements according to instructions due to consciousness disorder or cognitive decline.
•2) Patients who have difficulty in training joint exercises or wearing lumbar-type of HAL due to complications such as heart disease and musculoskeletal system, which are problems during exercise.
•3) Patients who cannot attach lumbar-type of HAL bio-electrode due to skin diseases.
•4) Patients who participated in other interventional studies within 12 weeks of the start of this clinical study.
•5) Patient who is judged to be medically unstable by the principal investigator or member doctors after comprehensively considering physical findings, examination findings, etc.

发起方

Matsumaru Yuji