UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036287 |
|---|---|
| Receipt number | R000041331 |
| Scientific Title | Clinical Application of a novel Robot for separate body weight support treadmill training in poststroke gait disorder |
| Date of disclosure of the study information | 2019/03/26 |
| Last modified on | 2023/10/01 17:22:11 |
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Basic information
Public title
Clinical Application of a novel Robot for separate body weight support treadmill training in poststroke gait disorder
Acronym
Clinical Application of a novel Robot for separate body weight support treadmill training in poststroke gait disorder
Scientific Title
Clinical Application of a novel Robot for separate body weight support treadmill training in poststroke gait disorder
Scientific Title:Acronym
Clinical Application of a novel Robot for separate body weight support treadmill training in poststroke gait disorder
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Treadmill training with or without partial body weight supported (BWS) is a task-oriented training for gait recovery. Previous studies suggest that body weight supported treadmill training (BWSTT) is effective to improve post-stroke gait disorder. Since conventional BWS continuously support both sides of the body, temporal support for each leg according to the gait cycle cannot be optimized. We developed a novel BWS robot to support the right and left body separately using pneumatic artificial muscles. We assessed whether the robot could modulate gait pattern in post-stroke hemiplegia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Symmetry indexes of stance phase and swing phase duration of gait.
Key secondary outcomes
Fugl-Meyer Assessment, 10-Meter walk test, Timed-Up and go test, Berg Balance Scale, kinematic data from the BWS robot and motion analysis system
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemiparetic patients with stroke
Key exclusion criteria
Dementia(MMSE<24), severe aphasia, severe heart, respiratory, and/or orthopedic diseases, pain
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Miyai |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research Institute
Zip code
536-0025
Address
2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
TEL
8-6-6969-0111
miyai@omichikai.or.jp
Public contact
Name of contact person
| 1st name | Misako |
| Middle name | |
| Last name | Miyata |
Organization
Morinomiya Hospital
Division name
Officer
Zip code
536-0025
Address
2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
TEL
8-6-6969-0111
Homepage URL
miyata@omichikai.or.jp
Sponsor or person
Institute
ATR Computational Neuroscience Labs, Dept. of Brain Robot Interface
Institute
Department
Personal name
Funding Source
Organization
NICT: National Institute of Information and Communications Technology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Omichi-kai Social Medical Corporation Ethics Committee
Address
2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
Tel
8-6-6969-0111
miyata@omichikai.or.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
森之宮病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 03 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041331
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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