UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041280 |
|---|---|
| Receipt number | 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 | 2025/02/07 11:20:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
eiichi@hirosaki-u.ac.jp
Sponsor or person
Institute
Dept of Rehabilitation Medicine, Hirosaki University, Graduate school of Medicine
Institute
Department
Personal name
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
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
10
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
Terminated
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
| 2025 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047137
