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) - Study NCY-3001

Takashi Nakajima0 sites30 target enrollmentDecember 26, 2013

Overview

Phase: N/A
Intervention: Not specified
Conditions: Not specified
Sponsor: Takashi Nakajima
Enrollment: 30
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

See the following UR

Registry

who.int

Start Date

December 26, 2013

End Date

October 31, 2014

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Takashi Nakajima

Eligibility Criteria

Inclusion Criteria

•1\.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

Exclusion Criteria

•1\.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;