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JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00203

Registered date:17/12/2014

A Multicenter, Baseline-controlled, Exploratory Study of Gait Improvement Effects Through a Gait Program Using a Dedicated Hoist in Patients with HTLV-1-associated Myelopathy (HAM)(Study HHH-1001)

Basic Information

Recruitment status Completed
Health condition(s) or Problem(s) studiedHTLV-1-associated Myelopathy (HAM)
Date of first enrollment17/02/2014
Target sample size10
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:PROCEDURE. Intervention1:Conventional gait training program with hoist, Dose form:OTHER, Route of administration:NOT APPLICABLE , intended dose regimen:The treatment period will be started from the day after Visit 1 and by 2 weeks after Visit 1. Following the evaluation at the start of the treatment period, the once-daily, 40-min gait program is to be implemented using the dedicated hoist for 9 sessions.Evaluation will occur 1 to 7 days (preferably within 3 days) after the last session of the gait program. The 9 sessions of the gait program should be completed within 13 weeks. The program may be implemented up to 4 times a week, but implementation for 3 or more consecutive days is not acceptable. The investigators will determine the frequency of implementation of gait program in consideration of subject conditions, such as muscle fatigue and pain.

Outcome(s)

Primary Outcome2-minute walk test. Timepoint:Visit1,2,5,8,11.
Secondary Outcome10-m walk test Osame's motor disability score (OMDS) Evaluation of spasticity (Modified Ashworth scale: MAS) Duration of lower extremity clonus (SCATS Clonus scale) Manual muscle test (MMT) ADL assessment (Barthel index). Timepoint: 10-m walk test Visit2,5,8,11.

Key inclusion & exclusion criteria

Age minimum>=18 YEARS
Age maximumNo Limit
GenderBOTH
Include criteria1)Capable of providing written consent. If the patient has sufficient ability to give consent but has difficulty writing due to 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, a person with 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 the signature of the patient; 3)Onset of HAM at least 2 years ago. 4)No abrupt changes in gait symptoms or changes in the grade of Osame's motor disability scale during the previous 3 months based on evaluation by the investigator or subinvestigator. 5)Incapable of walking 10 m independently and safely without a cane, walker, or handrail due to ambulation disorder associated with HAM but capable of walking 10 m or more with minor assistance, e.g., holding a handrail, walker, or movable hoist (an assistive device may be placed on the lower limb when necessary); 6)Capable of performing the visits on an outpatient or inpatient basis according to the study schedule during the study period
Exclude criteria1) Patients for whom gait training is considered difficult due to dyspnea on exertipn, heart failure, arrhythmia, myocardial infarction, or other conditions; 2) Patients complicated with spinal cord compression lesions due to spinal stenosis, such as spondylosis deformans, ossification of posterior longitudinal ligament, and calcification of ligamentum flavum, for whom gait training is considered difficult; 3) Patients for whom gait training is considered difficult due to severe skeletal deformation, such as osteoarthritis of the hip or knee, poorly controlled rheumatoid arthritis, and scoliosis; 4) Gait disturbance due to diseases of the brain, spinal cord, peripheral nerves, and muscles other than HAM. 5) Complications that cause problems in gait exercise, such as tendency to bleed 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) Administered the following drugs within 6 months of the pre-observation (Visit 1); Interferon-alpha Botox injection 9) Received steroid pulse therapy within 3 months of the pre-observation (Visit 1); 10) The daily dosage of the following drugs was changed within 2 months of the pre-observation (Visit 1); Steroids (other than topical application, such as skin application and inhalation) Salazosulfapyridine and other immunosuppressants Erythromycin Antispastics (tizanidine hydrochloride, eperisone hydrochloride, baclofen, etc.) Drugs for neuropathic pain (pregabalin, duloxetine hydrochloride, amitriptyline hydrochloride, clonazepam, etc.) 11) The daily dosage of the following drugs was changed within 2 weeks of the pre-observation (Visit 1); Vitamin C Casei Shirota strain 12) A rehabilitation program for gait improvement was newly started, discontinued, or significantly changed in frequency within 2 months of the pre-observation (Visit 1) 13) Bone fracture, bruise, trauma, or other complications necessitating hospitalization for treatment within 3 months of the pre-observation (Visit 1). 14) Pregnant patients and patients who may be pregnant; Patients willing to become pregnant during the study; 15) Participated in other clinical studies or clinical trials within 12 weeks of the pre-observation (Visit 1); 16) Underwent gait training using HALR for Well-being, etc. or wearing a dedicated hoist within 1 year. 17) 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,3-51 Akasaka-cho Kashiwazaki city Niigata prefecture,Zip code 945-8585
Telephone +81-257-22-2126
E-mail 225-kenkyuu@mail.hosp.go.jp
Affiliation Niigata National Hospital, National Hospital Organization
scientific contact
Name Takashi Nakajima
Address Department of Clinical research, Department of Neurology,3-51 Akasaka-cho Kashiwazaki city Niigata prefecture,Zip code 945-8585
Telephone +81-257-22-2126
E-mail
Affiliation National Niigata Hospital, National Hospital Organization