臨床研究等提出・公開システム

Revised Investigator-Initiated Clinical Study of Wearable Assistive Robot for Lower Limbs Controlled Voluntarily by Bioelectric Signals etc.,
(Hybrid Assistive Limb [HAL]-HN01) as a New Medical Device to Delay Progression of Intractable Rare Neuromuscular Diseases
-A Multicenter Randomized Controlled Parallel-Group Study to Evaluate the Short-Term Gait Improvement Effect on Ambulation Disability Caused by Spastic Paraplegia such as HTLV-1-Associated Myelopathy (HAM) etc.- (Study NCY-2001R) (Study NCY-2001R)

Revised Investigator-Initiated Clinical Study of Wearable Assistive Robot for Lower Limbs Controlled Voluntarily by Bioelectric Signals etc.,
(Hybrid Assistive Limb [HAL]-HN01) as a New Medical Device to Delay Progression of Intractable Rare Neuromuscular Diseases
-A Multicenter Randomized Controlled Parallel-Group Study to Evaluate the Short-Term Gait Improvement Effect on Ambulation Disability Caused by Spastic Paraplegia such as HTLV-1-Associated Myelopathy (HAM) etc.- (Study NCY-2001R)

42

Takashi Nakajima

Niigata National 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

Niigata National 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

COMPLETED

Sept. 23, 2016

Interventional

A multicenter randomized controlled parallel-group study

open(masking not used)

Yes

N/A

1.Patients who can provide his/her own written consent. If a subject has the ability to consent, but is not capable of handwriting due to progression of a source disease of gait dysfunction due to HAM, etc., a written consent may be obtained from a legal representative, after making sure that the subject him/herself has consented to the participation to this study.
2.Of age 18 or above at the time of obtaining consent. If a patient is a minor under the age of 20 at the time of consenting, signature or stamp from a parent or guardian is required in addition to the patient's signature or stamp.
3.Patients who have spent more than 2 years after developing a causal disease of gait dysfunction. Patients who have spent more than 6 months after undergoing surgical operation.
4.Patients without acute worsening in the walking abilities within the past 3 months. At Visit1 gait dysfunction must be stable.
5.Patients who, due to gait dysfunction from HAM etc. , are incapable of completing 10 m independent walks without the use of a cane, a walker or holding on to something, but are able to complete a walk of 10 m or more by light assistance, using a walker, mobile hoist (lower limb prostheses may be used when needed) or holding onto something.
6.Patients with a body weight between 40~100 kg, height of 150~190 cm, able to wear the HAL-HN01.However, even if the patient's height is outside the appropriated range, if the patient's thigh length, lower leg length and hip width are in range, the patient may wear the equipment.
7.Patients who are able to adhere to the study schedules during the study period, either by scheduled outpatient visits or hospitalization.

1.Patients who are judged to be unfit for gait training for reasons of dyspnea on exertion, heart failure, arrhythmia, myocardial infarction, etc.
2.Patients who are judged to have a difficulty in gait training, or worsen their symptoms from gait training, for reasons of deformed spinal canal stenosis such as spondylosis, ossification of posterior longitudinal ligament and yellow ligament calcification disease.
3.Patients who are judged to have a difficulty in gait training, or worsen their symptoms from gait training, for reasons of hip osteoarthritis, knee osteoarthritis, uncontrollable rheumatoid arthritis or severe deformation of the skeletal system due to scoliosis.
4.Patients that have developed walking disabilities through diseases of the brain, spinal cord, peripheral nerve and muscles from reasons other than the causal diseases of HAM etc -induced gait dysfunction.
5.Patients who have not underwent enough daily gait exercise for one month prior to Visit1. Patients whose distance result of 2MWT of Visit 6 improve more than 1.3 times better comparing to that of Visit 4
6.Patients with complications of bleeding tendencies and osteoporosis which are problematic for gait training.
7.Patients with serious liver/renal disorders or heart diseases (Serious diseases should be judged based on Grade 3 of "Severity Criteria for Drug Adverse Reaction" from Notice No.80 from the Safety Officer, Pharmaceutical Affairs Bureau, MHLW).
8.Patients with uncured malignant tumors.
9.Patients who have taken the below drugs within 6 months prior to Visit 1.
-Interferon-alpha
-Botox injections
10.Patients who have undergone steroid pulse therapy within 3 months prior to Visit 1.
11.Patients who have changed their daily dose of the following drugs, within 2 months prior to Visit 1.
-Steroidal drugs (excluding topical administrations and non-local administrations like inhalation)
-Salazosulfapyridine and other immunosuppressants
-Erythromycin
-Anti-spasticity drugs (Tizanidine hydrochloride, eperisone hydrochloride, baclofen)
-Drugs against neuropathic pain (Pregabalin, duloxetine hydrochloride, amitriptyline hydrochloride, clonazepam)
12.Patients who have undergone gait training through functional electrical stimulation, repetitive facilitated therapy (Kawahira method) or transcranial magnetic stimulation within 3 months prior to Visit 1.
13.Patients who had required hospitalized treatments due to broken bone, bruising, trauma or any other complications within 3 months prior to Visit 1.
14.Patients who are pregnant, or potentially pregnant. In addition, patients who wish to be pregnant during the study period.
15.Patients who cannot wear the HAL-HN01 body electrodes due to skin diseases, etc.
16.Patients who, at the pre-observational period, cannot perform hip exercises and knee joint exercises with the assist of CVC mode while wearing the HAL-HN01.Patients for whom the floor reaction sensor of HAL-HN01 does not work.
17.Patients who had participated in another clinical trial within 3 months prior to Visit 1.
18.Patients who had gait training while wearing welfare-purpose HAL within 1 year prior to Visit 1.
19.Patients for were judged to be ineligible to participate in this study, by the principal investigator or the subinvestigators.

Both

The target disease condition of this study is ambulation disability caused by spastic paraplegia resulting from HTLV-1-Associated Myelopathy (HAM) according to HAM/TSP diagnostic guidelines (from the 1988 Kagoshima WHO Scientific Council), as well as ambulation disability occurring from chronic monophasic spastic paraplegia similar to HAM resulting from other causes (hereinafter, "Ambulation disability caused by HAM, etc."). Examples of diseases and conditions to be included in chronic monophasic spastic paraplegia are: hereditary spastic paraplegia, traumatic spinal cord injury, spinal vascular disorders, myelitis, cured spinal cord tumors, ossification of posterior longitudinal ligament that is orthopedically stable due to surgeries and allows for the burden of walking, ossification of yellow ligament, and spondylosis as non-traumatic spinal cord injuries, and conditions clinically equivalent to these diseases though its cause cannot be identified as one of the aforementioned.

Intervention type:DEVICE Name of intervention:Gait training program using HAL-HN01 with hoist Dose form / Japanese Medical Device Nomenclature:DEVICE HAL-HN01 Route of administration / Site of application:NOT APPLICABLE Dose per administration:40 minutes Dosing frequency / Frequency of use:OTHER, SPECIFY 9 times Planned duration of intervention:short term period Intended dose regimen:After walk ability of the patient with HAL is confirmed, once a day up to 4 times a week, 40-min gait program is to be implemented using HAL-HN01 with hoist for a total of 9 gait programs. Evaluation will occur 2 to 14 days after the last gait program. A total of 9 gait programs should be completed within one month. detailes of teratment arms:This gait program is defined as walk training lasting for a total of 40 min, consisting of warming up, walking exercise, and cooling down. Before gait program and during gait program, walk ability with HAL of the patient should be confirmed and adjust appropriately the setting of HAL. The walking exercise using HAL-HN01 with hoist will be started after warming up for about 5 min. After the walking exercise, stretching of extremities and trunk will be performed for the cooling down period. During the walking exercise, the subject may rest depending on his/her condition; however, the total walking time should be at least 20 minutes up to 30 minutes. A gait program using the assistance of CAC mode nor CIC mode of HAL-HN01 alone should not be performed as the gait program. Comparative intervention name:Conventional gait training program with hoist Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application:NOT APPLICABLE Dose per administration:40 minutes Dosing frequency / Frequency of use:OTHER, SPECIFY 9 times Planned duration of intervention:short term period Intended dose regimen:Conventional gait Program with hoist-9 times method:Following the evaluation at the start of the treatment period, the once-daily, 40-min conventional gait program is to be implemented with hoist for a total of 9 visits. Evaluation will occur 2 to 14 days after the last gait program. A total of 9 gait programs should be completed within one month.

2-min walk test

10 m walk test
Patient's subjective assessment of gait (Patient-reported outcome measure: PRO)
Medical practitioner's assessment of gait
Osame's Motor Disability Score (OMDS)
Spasticity assessment (Modified Ashworth Scale: MAS)
Lower extremity clonus duration (SCATS Clonus scale)
Manual Muscle Test (MMT)
Assessment of activities of daily living (ADL) (Barthel index)
Operator's assessment of the use of HAL-HN01

+81-257-22-2126

+81-257-22-0277

July. 27, 2016