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Multi-center observational study and present status survey for the establishment of the standard method for the long-term use of HAL. (NCY extended03)

Multi-center observational study and present status survey for the establishment of the standard method for the long-term use of HAL.

Takashi Nakajima

National Niigata Hospital, National Hospital Organization

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

nakajima.takashi.ud@mail.hosp.go.jp

Takashi Nakajima

National Niigata Hospital, National Hospital Organization

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

+81-257-22-2126

225-kenkyuu@mail.hosp.go.jp

RECRUITING

Aug. 12, 2019

Observational

Prospective and Retrospective Observational Study

open(masking not used)

No

N/A

(1) Patients for whom at least one course of treatment using HAL was performed, and the conditions before and after the course were evaluated, or such a course and evaluation are planned
(2) Patients who can opt out using consent written by themselves or using a prescribed method.Patients who can provide his/her own written consent. For patients aged 16 or older and under 20, informed consent by legal guardian is required in addition to him/her consent. For patients under 16, obtaining informed assent by him/her is encouraged after explaining the study in readily comprehensible language. If the patient has sufficient ability to consent but has difficulty writing due to primary disease progression, written consent is to be obtained from the patient's legally acceptable representative after confirming that the subject himself/herself consents to participate in the study;

(1)In the case that patient's length and shape are not fit to "HAL(Lower Limb Type)".
(2)In the case that patient is not allowed to stand and/or walk with "HAL(Lower Limb Type)".
(3)In the case that electrodes are not allowed to be put on the patient's skin because of the patient's skin disease.
(4)Ineligibility for participating in this study according to the investigator or subinvestigator.
The above (1)-(3) correspond to contraindications/prohibitions for HAL for medical use (lower limb-type).

Both

The subjects will consist of patients with reduced walking function due to slowly progressive neurological/muscular diseases. HAL for medical use (lower limb type) is indicated for the following slowly progressive neurological/muscular diseases:spinal muscular atrophy (SMA), spinal and bulbar muscular atrophy (SBMA), amyotrophic lateral sclerosis (ALS), Charcot-Marie-Tooth disease (CMT), distal myopathy, inclusion body myositis (IBM), congenital myopathy, and muscular dystrophy. Patients who were diagnosed with one of the 8 diseases and require walking assistance or aids will be included as subjects. In addition, even patients who were not definitively diagnosed with one of the above 8 diseases but use HAL in daily medical practice at the attending physician's discretion will be included as subjects.

Intervention type: Name of intervention: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen: detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:

Status of cybernetic walk treatment using HAL 2-min walk test;the distance (m) walked at the fastest speed for 2 minutes

10-m walk test (speed);the maximum walk speed (m/s), mean stride length (m/sep), and cadence (step/sec)
Manual muscle test (MMT);hip flexion and extension, knee flexion and extension, and right and left ankle dorsiflexion, and plantar flexion
Barthel index
Japanese version of the DRS
Body weight
Blood creatine kinase level

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