臨床研究等提出・公開システム

Longterm outcome survey of "HAL for Medical Use (Lower Limb Type)"
(Use result survey of " HAL for Medical Use (Lower Limb Type)")

Outcome survey of " HAL for Medical Use (Lower Limb Type)"

220

Takashi Nakajima

Niigata National Hospital, National Hospital Organization

3-52 Akasaka-cho Kashiwazaki city Niigata prefecture,Zip code 945-8585

kenkyuuhan@niigata-nh.go.jp

Makoto Nihei

CYBERDYNE, INC.

2-2-1, Gakuen-Minami, Tsukuba, Ibaraki, 305-0818 Japan

+81-29-869-8450

nihei_makoto@cyberdyne.jp

COMPLETED

July. 05, 2017

Observational

Open Cohort

open(masking not used)

No

N/A

Inclusion criteria must be in accordance with the approved label of "HAL for Medical Use (Lower Limb Type)"
Briefly, the patients of the neuromuscular diseases including spinal muscular atrophy, spinal bulbar muscular atrophy, muscular dystrophy, Charcot-Marie Tooth disease, distal myopathy, sporadic inclusion body myositis, congenital myopathy, and amyotrophic lateral sclerosis who have gait disorder.
Body weight ranges from 40 to 100 kg. Body length range approximately from 150 to 190 cm. Lower limb length must be fit to the device length. The patients who are able to wear "HAL for Medical Use (Lower Limb Type)".

In the case that patient's length and shape are not fit to "HAL for Medical Use (Lower Limb Type)". In the case that patient is not allowed to stand and/or walk with "HAL for Medical Use (Lower Limb Type)". In the case that electrodes are not allowed to be put on the patient's skin because of the patient's skin disease.

Both

The neuromuscular diseases including spinal muscular atrophy, spinal bulbar muscular atrophy, muscular dystrophy, Charcot-Marie Tooth disease, distal myopathy, sporadic inclusion body myositis, congenital myopathy, and amyotrophic lateral sclerosis

Intervention type:DEVICE Name of intervention:Cybernic treatment using "HAL for Medical Use (Lower Limb Type)" Dose form / Japanese Medical Device Nomenclature:DEVICE " HAL for Medical Use (Lower Limb Type)" Route of administration / Site of application:NOT APPLICABLE Dose per administration:20-40min walk treatment using " HAL for Medical Use (Lower Limb Type)" with hoist Dosing frequency / Frequency of use:OTHER, SPECIFY once and less than once in a day Planned duration of intervention:long term observation, max duration is 40 months. Intended dose regimen:9 times of cybernic treatment is defined as 1 course of cybernic treatment detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:

2-min walk test (Distance)

10 m walk test (Time, Steps)
Manual Muscle Test (MMT)
Assessment of activities of daily living (ADL) (Barthel index)
Quality of life (QOL)(EQ-5D-5L index, EQ-5D-5L VAS, Patient Reported Outcome (Japanese Version of the Decision Regret Scale), Free comment)
serum Creatine Kinase

+81-257-22-2126

+81-257-22-7728

Feb. 14, 2017