UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043887 |
|---|---|
| Receipt number | R000050096 |
| Scientific Title | Preliminary study of the effect of walkers and rehabilitation robots for physically handicapped children with neurological impairments |
| Date of disclosure of the study information | 2021/04/11 |
| Last modified on | 2022/04/12 09:30:39 |
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Basic information
Public title
Preliminary study of the effect of walkers and rehabilitation robots for physically handicapped children with neurological impairments
Acronym
The effects of walkers and rehabilitation robots for children with neurological impairments
Scientific Title
Preliminary study of the effect of walkers and rehabilitation robots for physically handicapped children with neurological impairments
Scientific Title:Acronym
The effects of walkers and rehabilitations robots for children with neurological impairments
Region
| Japan |
Condition
Condition
motor deficits due to central nervous system impairments
Classification by specialty
| Pediatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to investigate the effects of walkers and rehabilitation robots for physically handicapped children with neurological disorders (GMFCS level III, IV, V).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
gait speed, stride length, gait cycle time
Key secondary outcomes
Root Mean Square of electromyography, trunk angle
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
| 7 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) ages 7 to 18 years old
2) Gross Motor Function Classification System levels III, IV, V
3) motor deficits with central nerve system impairments
4) height over 90cm, weight over 90kg
5) the doctor judged the participants could walk with the walker
6) able to understand the instruments such as walk or stop
7) able to express fatigue, pain, or need to take a rest
Key exclusion criteria
1)severe epilepsy and not able to participate in the study
2)the doctor judged the participants could not stay in the laboratory for 2 hours
3) deformity or contracture which impairs gait
4)not able to use the walker or put the electrode of the electromyography on the skin
5) respiratory, cardiovascular, urinary or digestive disorders that affects motor movements
6) does not fit the size of the walkers and the devices
7) behavioral disorders which affects the participation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Ohata |
Organization
Graduate school of Medicine, Kyoto University
Division name
Department of Human Health Sciences
Zip code
606-8507
Address
53 Kawaharacho, Shogoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3918
ohata.koji.7n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Ohata |
Organization
Graduate school of Medicine, Kyoto University
Division name
Department of Human Health Sciences
Zip code
606-8507
Address
53 Kawaharacho, Shogoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3918
Homepage URL
ohata.koji.7n@kyoto-u.ac.jp
Sponsor or person
Institute
Department of Human Health Sciences, Graduate school of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Honda R&D Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Graduate School and Faculty of Medicine Kyoto University
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto city, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2021 | Year | 04 | Month | 11 | 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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
-
Management information
Registered date
| 2021 | Year | 04 | Month | 11 | Day |
Last modified on
| 2022 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050096
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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