NIPH Clinical Trials Search

A study to evaluate the effects of gait exercise therapy using the HAL Medical Lower Limb Type by measuring muscle activity and body motion during walking

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Neuromuscular diseases and other conditions with gait impairment in which HAL is used clinically
Date of first enrollment	30/04/2026
Target sample size	20
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

Change in surface electromyography (EMG) RMS values, calculated using gait cycle analysis based on IMU sensor data

Secondary Outcome

1) Change in walking distance during the 2-minute walk test (2MWT) 2) Change in cycle-integrated RMS values per gait cycle 3) Change in the ratio of 2MWT walking distance to cycle-integrated RMS values (index of neuromuscular efficiency) 4) Change in co-contraction time during the 2MWT 5) Change in Borg Rating of Perceived Exertion (RPE) 6) Change in gait parameters calculated from IMU sensor data, including walking speed, stride length, stance and swing phase durations, and trunk stability indices 7) Change in manual muscle testing (MMT) scores, including bilateral hip flexion/extension, knee flexion/extension, and ankle dorsiflexion/plantarflexion, as well as the composite MMT score 8) Change in qualitative gait pattern assessment based on video recordings 9) Change in serum creatine kinase (CK) levels 10) Change in serum creatinine (Cre) levels 11) Other clinically significant changes in blood test parameters

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	1) 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. 2) 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. 3) 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. 4) 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.
Exclude criteria	1) 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. 2) 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. 3) Individuals in whom electrodes or sensors for surface electromyography measurement cannot be attached because of skin disease or other conditions. 4) 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. 5) Individuals otherwise judged by the principal investigator to be inappropriate as participants in this observational study. 6) 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.