UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028017 |
|---|---|
| Receipt number | R000032078 |
| Scientific Title | Study to evaluate effects of robot suit HAL in combination with acupuncture treatment |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2023/07/05 09:30:39 |
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Basic information
Public title
Study to evaluate effects of robot suit HAL in combination with acupuncture treatment
Acronym
Study to evaluate effects of robot suit HAL in combination with acupuncture treatment
Scientific Title
Study to evaluate effects of robot suit HAL in combination with acupuncture treatment
Scientific Title:Acronym
Study to evaluate effects of robot suit HAL in combination with acupuncture treatment
Region
| Japan |
Condition
Condition
Movement disorder
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to contribute to restoration of motor function by rehabilitation using HAL, in combination with acupuncture or moxibustion treatment to reduce spasm and flaccid of muscle that interfere with walking training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Barthel Index
Key secondary outcomes
1.Brunnstrom stage
2.Fugl-Meyer Assessment
3.Modified Ashworth Scale
4.10m walking test
5.chair-stand test
6.Functional Independence Measure
7.VAS
8.Subjective walking evaluation
9.Myogenic Potential Measuring Apparatus
10.fNIRS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Acupuncture treatment
Exercise training using HAL
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with lower limb motor paralysis who have good conscious state and stable state of the whole body, and can judge safety, danger etc.
Key exclusion criteria
1. Significant lower limb joint disability (strong deformation, inflammation, dislocation, etc.)
2. Cardiac pacemaker wearer, Pregnant
3. Higher brain dysfunction, dementia, severe sensory disorder
4. Difficult to hold the sitting posture
5. Do not fit the size of HAL
6. Abdominal pressure difficulty
7. Judged by doctors not to be applied
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Arima |
Organization
Suzuka University of Medical Science
Division name
Institute of Traditional Chinese Medicine
Zip code
510-0226
Address
1275-3, Kishioka,Suzuka-city, Mie, JAPAN
TEL
059-381-2385
maning@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | kawanokuchi |
Organization
Suzuka University of Medical Science
Division name
Institute of Traditional Chinese Medicine
Zip code
510-0226
Address
1275-3, Kishioka,Suzuka-city, Mie, JAPAN
TEL
059-381-2385
Homepage URL
kawa-jun@suzuka-u.ac.jp
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
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
Suzuka University of Medical Science
Address
1275-3, Kishioka,Suzuka-city, Mie, JAPAN
Tel
059-381-2385
kawa-jun@suzuka-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
| 2017 | Year | 07 | Month | 01 | 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
Suspended
Date of protocol fixation
| 2017 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 21 | 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
| 2017 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032078
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
