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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041280
Receipt No. R000047137
Scientific Title Effects of gait training with a voluntary driven Wearable Cyborg, Hybrid Assistive Limb (HAL), in patients with spinal cord disease
Date of disclosure of the study information 2020/08/03
Last modified on 2020/08/03

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Basic information
Public title Effects of gait training with a voluntary driven Wearable Cyborg, Hybrid Assistive Limb (HAL), in patients with spinal cord disease
Acronym Treatment with Hybrid Assistive Limb (HAL), in patients with spinal cord disease
Scientific Title Effects of gait training with a voluntary driven Wearable Cyborg, Hybrid Assistive Limb (HAL), in patients with spinal cord disease
Scientific Title:Acronym Treatment with Hybrid Assistive Limb (HAL), in patients with spinal cord disease
Region
Japan

Condition
Condition spinal cord disease
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects of HAL-supported gait training in patients with spinal cord disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The parameters were measured before
treatment, 3 month after treatment.
1. JOA score
2. ADL score(Barthel index,Functional Independence Measure)
3. Patient-standing QOL score(SF36,EuroQOL-5D)
4. 10-m walk test
5. 6-min walk test
6. Tilt of the trunk and angle of hips, knees and ankles during walking
7. Lower extremity muscle activity during walking (gluteus maximus, gluteus medius, quadriceps, hamstring, tibialis anterior, triceps surae)
8. Signal intensity of nerve conduction path in simple MRI images (Synthetic MRI, Quantitative Susceptibility Mapping, diffusion tensor image, 3D-MRI, 3D-FLAIR, Finger-Printing)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In group A, walking rehabilitation using HAL is performed for 3 months, and then conventional walking rehabilitation centered on assisted walking training by a therapist is performed for 3 months.
Interventions/Control_2 In Group B, conversely, conventional walking rehabilitation is performed for 3 months, and then walking rehabilitation using HAL is performed for 3 months.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria More than 6 months have passed since the onset of spinal cord disease or surgical treatment.
Lower limb dysfunction due to spinal cord disease remains, resulting in a decline in walking ability.
As for spinal cord injury, ASIA dysfunction scales C and D are used.
It is possible to walk for 10 meters or more without support or using a walking aid.
Key exclusion criteria Other central nervous system diseases, nerve/muscle diseases, or locomotor system diseases clearly influence the deterioration of walking ability.
HAL is difficult to wear due to severe deformation of limbs and trunk caused by osteoarthritis, spondylosis, scoliosis, etc.
It is difficult to follow the instructions due to severe dementia.
Has respiratory, circulatory, and metabolic system dysfunction, bleeding tendency, and osteoporosis, which are problems in training.
Biomedical electrodes cannot be attached due to skin diseases.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Ishiyama
Organization Hirosaki University, graduate school of Medicine
Division name Dept. of Rehabilitation Medicine
Zip code 036-8562
Address 5 Zaifu-cho, Hirosaki, AOMORI
TEL 0172-33-5111
Email a.b.c.hiro77@gmail.com

Public contact
Name of contact person
1st name Eiichi
Middle name
Last name Tsuda
Organization Hirosaki University, Graduate School of Medicine
Division name Dept. of Rehabilitation Medicine
Zip code 036-8562
Address 5 Saifu-cho, Hirosaki, AOMORI
TEL 0172-33-5111
Homepage URL
Email eiichi@hirosaki-u.ac.jp

Sponsor
Institute Dept of Rehabilitation Medicine, Hirosaki University, Graduate school of Medicine
Institute
Department

Funding Source
Organization NA
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hirosaki University, Graduate School of Medicine
Address 5 Zaifu-cho, Hirosaki, AOMORI
Tel 0172-33-5111
Email rinri@hirosaki-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 03 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 07 Month 22 Day
Date of IRB
2020 Year 07 Month 22 Day
Anticipated trial start date
2020 Year 07 Month 31 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 03 Day
Last modified on
2020 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047137

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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