JPRN-jRCT1092220204
Completed
N/A
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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Takashi Nakajima
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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 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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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