A study of surface electromyographic activity (RMS) and IMU-based motion assessment as biomarkers for evaluating the effectiveness of gait exercise therapy using the HAL Medical Lower Limb Type

未提供0 个研究点目标入组 20 人开始时间: 待定

试验速览

阶段: 不适用
状态: 招募中
入组人数: 20

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Observational

入排标准

年龄范围: No limit 至 No limit（—）
性别: All

入选标准

•Patients
•Patients who are receiving, or are scheduled to receive, HAL gait exercise therapy at NHO Niigata National Hospital, and who have received a full explanation of this study and provided written informed consent. If the patient is under 18 years of age, or if intellectual disability or cognitive impairment may make it difficult for the patient to sufficiently understand and judge the research content, written informed consent will be obtained from an appropriate legally acceptable representative.
•Completion of at least one course of HAL gait training with pre and post evaluation
•Patients who have undergone, or are scheduled to undergo, at least one course of gait training using HAL, with routine gait assessments performed before and after the course. In this study, one course is defined, in principle, as a series of gait exercise therapy sessions consisting of approximately nine HAL sessions. However, because the number of sessions may vary in actual clinical practice depending on the patient's condition and schedule, a consecutive series of HAL sessions performed between the pre and post evaluations will be treated as one course. Both first time HAL users and continuing HAL users are eligible.
•Target diseases
•The main target diseases are the ten neuromuscular disorders for which the HAL Medical Lower Limb Type or the Medical HAL Lower Limb Type B is indicated and covered by health insurance in Japan: spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal myopathy, inclusion body myositis, congenital myopathy, muscular dystrophy, HTLV-1 associated myelopathy, and hereditary spastic paraplegia. In addition, patients with cerebral palsy, post stroke conditions, and other disorders in which HAL is used clinically at the discretion of the attending physician may also be included. In such cases, the HAL Lower Limb Type for Well Being may be used, and depending on body size or other practical considerations, off label use of the HAL Medical Lower Limb Type or the Medical HAL Lower Limb Type B may also be included.
•Healthy volunteers
•Healthy volunteers may also be included for the purpose of preparing and confirming the measurement procedures used in this study. Healthy volunteers must receive an explanation of the study and provide written informed consent. For healthy volunteers, only surface electromyography RMS and IMU measurements will be performed, and no routine clinical data or HAL pre and post treatment comparisons will be collected.

排除标准

•Individuals whose body size, including body weight, thigh length, lower leg length, or pelvic width, does not fit the HAL devices used at NHO Niigata National Hospital, or individuals for whom HAL attachment is difficult because of marked body deformity or similar reasons.
•Individuals judged by the attending physician to be unsuitable for participation in the study, including those for whom standing or gait training is considered inappropriate.
•Individuals in whom electrodes or sensors for surface electromyography measurement cannot be attached because of skin disease or other conditions.
•Individuals using medical devices for which the use of the Delsys Trigno Wireless System is contraindicated, such as cardiac pacemakers, electronic infusion pumps, or implanted stimulators.
•Individuals otherwise judged by the principal investigator to be inappropriate as participants in this observational study.
•Items 1 to 3 are related to the contraindications and prohibited conditions described in the package inserts for the HAL Medical Lower Limb Type and the Medical HAL Lower Limb Type B. Item 4 corresponds both to a contraindication for use of the Delsys Trigno Wireless System and to a condition in which the HAL Lower Limb Type for Well Being cannot be used.

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