NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00156

Registered date:26/12/2013

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-Randomized, Controlled, Crossover Study for Gait Improvement as a Short-Term Effect (Study NCY-3001)

Basic Information

Recruitment status Completed
Health condition(s) or Problem(s) studiedThe target disease condition of this study is ambulation disorder due to intractable rare neuromuscular diseases. Examples of diseases and conditions to be included are: spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis with slowly progressive lower-limb symptoms, Charcot-Marie-Tooth disease, distal myopathy, sporadic inclusion body myositis, congenital myopathy, muscular dystrophy, and conditions considered equivalent to these diseases though not definitively diagnosed.
Date of first enrollment06/03/2013
Target sample size30
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:DEVICE. Intervention1:Gait training program using HAL-HN01 with hoist, Dose form:DEVICE, Route of administration:NOT APPLICABLE , 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 occur 1 to 3 days after the last visit. A total of 9 visits should be completed within 13 weeks. . Control intervention1:Conventional gait training program with hoist, Dose form:OTHER, Route of administration:NOT APPLICABLE , 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 1 to 3 days after the last visit. A total of 9 visits should be completed within 13 weeks. .

Outcome(s)

Primary Outcome2-min walk test. Timepoint:Visit 4,13,14,23.
Secondary Outcome10-m walk test (speed) Patient's subjective assessment of gait (Patient-reported outcome measure: PRO) Medical practitioner's assessment of gait Manual muscle test (MMT) Assessment of activities of daily living (ADL) (Barthel index) Operators' assessment of the use of HAL-HN01. Timepoint: Visit 4,13,14,23.

Key inclusion & exclusion criteria

Age minimum>=18 YEARS
Age maximumNo Limit
GenderBOTH
Include criteria1.Capable of providing written consent by himself/herself. 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; 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.No rapid changes in gait symptoms during the last 3 months as assessed by the investigator or subinvestigator; 4.Incapable of walking 10 m independently and safely without a cane, walker, or handrail due to unstable gait associated with the above-mentioned target diseases 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); 5.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; 6.Capable of performing the visits on an outpatient or inpatient basis according to the study schedule during the study period
Exclude criteria1.Use of a mechanical ventilator, respiratory assistance devices, or oxygen therapy or requirement for such devices or therapy as assessed by the investigator or subinvestigator; 2.Patients for whom gait training is considered difficult due to exertional dyspnea, cardiac failure, or other conditions; 3.Patients for whom gait training is considered difficult due to severe skeletal deformation, such as osteoarthritis of the hip, knee, or spine and scoliosis; 4.Gait disturbance due to diseases of the brain, spinal cord, peripheral nerves, and muscles other than neuromuscular diseases relevant to this study; 5.Patients for whom gait training is considered difficult due to other complications including bleeding tendency and osteoporosis 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.Initiation or discontinuation of the following treatments within 2 months of the pre-observation period: New gait rehabilitation program for lower limbs; administration of steroid other than focal treatment, such as skin application or inhalation; administration of riluzole; administration of sodium valproate; and administration of any drug intended to inhibit progression of diseases that are targets of this study; 9.Bone fracture, bruise, trauma, or other complications necessitating hospitalization for treatment within 3 months of the pre-observation period; 10.Pregnant or possibly pregnant patients and patients who wish to become pregnant during the study period; 11.Unable to have the HAL-HN01 bioelectrode attached on the body due to, for example, a skin disease; 12.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; 13.Participation in another clinical study within 12 weeks prior to the pre-observation period; 14.Underwent gait training with HAL-welfare model within 1 year; 15.Ineligibility for participating in this study according to the investigator or subinvestigator

Related Information

Contact

public contact
Name Takashi Nakajima
Address Department of Clinical research, Department of Neurology,3-52 Akasaka-cho Kashiwazaki city Niigata prefecture,Zip code 945-8585
Telephone +81-257-22-2126
E-mail 225-kenkyuu@mail.hosp.go.jp
Affiliation National Niigata Hospital, National Hospital Organization
scientific contact
Name Takashi Nakajima
Address Department of Neurology,3-52 Akasaka-cho Kashiwazaki city Niigata prefecture,Zip code 945-8585
Telephone +81-257-22-2126
E-mail
Affiliation Niigata National Hospital, National Hospital Organization