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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030667
Receipt No. 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

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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
Email 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
Email ohata.koji.7n@kyoto-u.ac.jp

Sponsor
Institute Department of Human Health Sciences, Graduate school of Medicine, Kyoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033737

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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