Pilot study using HAL lower limb type (2S size) for children with developmental non-progressive motor dysfunction such as cerebral palsy - Pilot study using HAL for children with developmental non-progressive motor dysfunction

Marushima Aiki0 个研究点目标入组 15 人开始时间: 2020年5月26日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Patients who meet all of the following inclusion criteria and do not meet any of the exclusion criteria are eligible for this study enrollment.
•1) Patients who can give written consent by their substitute.
•2) Patients aged 5-15 years.
•3) Patients with Level 2-4 of GMFCS (Gross Motor Function Classification System).
•4) Patients more than 1 year after onset.
•5) Patients who can wear HAL lower limb type 2S size prototype and its improved equipment.
•(The height is assumed to be 100-150cm, but the usage condition is not for height but for patients who fit the body size such as thigh length, lower leg length, waist width)
•6) Patients who can continue hospitalization or go outpatient according to the study schedule during the study period.

•Patients who conflict with one of the following criteria are excluded and not subject to this clinical study.
•1) Patients who have difficulty performing voluntary limb movements according to instructions due to impaired consciousness or severe Intellectual disability.
•2) Patients whose skeletal system such as osteoarthritis, spondyloarthropathy, scoliosis, etc. is severely deformed and difficult to train including joint movement or wear HAL.
•3) Patients who have complications such as bleeding tendency or osteoporosis which may cause training problems.
•4) Patients who cannot be put on the electrode on the skin surface due to a skin disease etc.
•5) Patients who participated in other studies within 12 weeks of the start of this clinical study.
•6) Patients who are considered inappropriate to participate in this study by the principal investigator or member doctors of the study.

发起方

Marushima Aiki