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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-2001) (Study NCY-2001)

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-2001)

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. 18, 2014

Interventional

A multicenter randomized controlled parallel-group study

open(masking not used)

Yes

N/A

1) Capable of providing written consent by himself/herself. If the patient has sufficient ability to consent but has difficulty writing due to progression of primary disease of ambulation disability caused by HAM, etc., written consent is to be obtained from the patient's legally representative after confirming that the subject himself/herself consents to participate in the study;
2) Aged 18 years or older at the time of providing consent. In the case of minors aged less than 20 years, the person in parental authority or the guardian is required to affix their name and seal or sign the consent form in addition to the name and seal or signature of the patient;
3) Have spent more than 2 years after developing a causal disease of ambulation disability caused by HAM, etc.;
4) No rapid changes gait symptoms during the last 3 months;
5) Incapable of walking 10 m independently and safely without a cane, walker, or handrail due to unstable gait associated with HAM, etc. but capable of walking 10 m or more with minor assistance, holding a handrail, walker, or movable hoist (assistive device may be placed on the lower limb when necessary);
6) Body weight of 40 to 100 kg and height of 150 to 190 cm to allow for HAL-HN01 use.Patients are eligible if their body size (e.g., femur length, lower leg length, and hip width) fits with the device and allows for wearing HAL-HN01, even if the height is not in the above range;
7) Capable of performing the visits on an outpatient or inpatient basis according to the study schedule during the study period.

1) Patients for whom gait training is considered difficult due to exertional dyspnea, cardiac failure, arrhythmia, myocardial infarction, etc.;
2) Patients for whom gait training is considered difficult or to worsen their symptoms due to spinal canal stenosis such as spinal osteoarthritis, ossification of posterior longitudinal ligament and ossification of yellow ligament;
3) Patients for whom gait training is considered difficult or to worsen their symptoms due to severe skeletal deformation, such as osteoarthritis of the hip or knee, uncontrollable rheumatoid arthritis and scoliosis;
4) Gait disturbance due to diseases of the brain, spinal cord, peripheral nerves, and muscles other than the causal diseases of ambulation disability caused by HAM, etc.;
5) Patients with a complication such as bleeding tendency and osteoporosis which is problematic in gait training;
6) Serious hepatic disorder, renal disorder, or cardiovascular disease ("serious diseases" will be assessed using Grade 3 as specified in the Seriousness Grading Criteria for Adverse Reactions to Pharmaceuticals [PAB/SD Notification No. 80 issued by Director, Safety Division, Pharmaceutical Affairs Bureau, MHW] as a reference);
7) Malignant tumor that has not been completely cured;
8) Received the drugs below within 6 months prior to Visit 1.
-Interferon-alpha
-Botox injections
9) Underwent steroid pulse therapy within 3 months prior to Visit 1;
10) Patients who changed their daily dose of the following drugs, within 2 months prior to Visit 1.
-Steroids (excluding focal treatment, such as skin application and inhalation)
-Salazosulfapyridine and other immunosuppressants
-Erythromycin
-Antispasmogenics (tizanidine hydrochloride, eperisone hydrochloride, baclofen, etc.)
-Drugs against neuropathic pain (pregabalin, duloxetine hydrochloride, amitriptyline hydrochloride, clonazepam, etc.)
11) Underwent gait training with the use of a mobile hoist, repetitive facilitation exercise therapy (Kawahira Method), or gait training through functional electrical stimulation within 3 months prior to Visit 1;
12) Initiation or discontinuation of rehabilitation program, or significant change in the frequency of the program intended for gait improvement within 2 months prior to Visit 1;
13) Bone fracture, bruise, trauma, or other complications necessitating hospitalization for treatment within 3 months prior to Visit 1;
14) Pregnant or possibly pregnant patients and patients who wish to become pregnant during the study period;
15) Unable to have the HAL-HN01 bioelectrode attached on the body due to, for example, a skin disease;
16) Incapable of moving the hip or knee with HAL-HN01 providing assistance in CVC mode during the pre-observation period. Patients for whom the floor reaction force sensor of HAL-HN01 does not react;
17) Participation in another clinical study within 3 months prior to Visit 1;
18) Underwent gait training with HAL for Well-being within 1 year prior to Visit 1;
19) Ineligibility for participating in this study according to the investigator or subinvestigator.

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 individually appropriate assist minutes Dosing frequency / Frequency of use:OTHER, SPECIFY 9 times Planned duration of intervention:short term period Intended dose regimen:Gait program using HAL-HN01 with hoist - 9times method:Following the evaluation at the start of the treatment period, the once-daily, 40-min gait program is to be implemented using HAL-HN01 with hoist for a total of 9 visits. Evaluation will occur2 to 7 days after the last visit. A total of 9 visits should be completed within 13 weeks. 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. 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. A gait program using the assistance of CAC 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:OTHER 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 7 days after the last visit. A total of 9 visits should be completed within 13 weeks.

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