UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030667 |
|---|---|
| Receipt number | R000033737 |
| Scientific Title | The effects of Honda Waking Assist on gait for children with cerebral palsy |
| Date of disclosure of the study information | 2018/01/03 |
| Last modified on | 2018/10/08 18:29:23 |
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Basic information
Public title
The effects of Honda Waking Assist on gait for children with cerebral palsy
Acronym
The effects of Honda Walking Assist
Scientific Title
The effects of Honda Waking Assist on gait for children with cerebral palsy
Scientific Title:Acronym
The effects of Honda Walking Assist
Region
| Japan |
Condition
Condition
cerebral palsy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the effects of Honda Walking Assist on gait performance, kinematic pattern, muscle activation during gait in children with cerebral palsy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
gait speed (6-meters walk), CV of gait, variability of gait time and pattern, step length, single stance time and symmetry, muscle activation(Rectus Femoris, Semitendinosus, Tibial Anterior, lateral Gastrocnemius on both legs)
Key secondary outcomes
Gross Motor Function Classification System
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
On the first day, subjects practice gait for 30seconds x 10times on the treadmill with robotic assist.
Then on the second day, although the subjects wear the robot on their body, they practice walking for 30seconds x 10times on the treadmill with no robotic assist.
Interventions/Control_2
On the first day, although the subjects wear the robot on their body, they practice walking for 30seconds x 10times on the treadmill with no robotic assist.
Then on the second day, subjects practice gait for 30seconds x 10times on the treadmill with robotic assist.
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
| 5 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Cerebral palsy(Gross Motor Function Classification System I-III)
2)able to walk continuously for about 500 meters without any help
3)able to understand experimental tasks to perform continuous walking
4)hip width over 25cm
Key exclusion criteria
1)the presence or history of orthopedic diseases that limit walking
2)the presence or history of cardiopulmonary disease that limit walking
3)not able to understand experimental tasks to perform continuous walking
4)not able to fit to the device size
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Ohata |
Organization
Graduate school of Medicine, Kyoto University
Division name
Department of Human Health Sciences
Zip code
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 | |
| Middle name | |
| Last name | Koji Ohata |
Organization
Graduate school of Medicine, Kyoto University
Division name
Department of Human Health Sciences
Zip code
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
Address
Tel
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
| 2018 | Year | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 07 | 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
| 2018 | Year | 01 | Month | 03 | Day |
Last modified on
| 2018 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033737
| 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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