UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of Honda Waking Assist on gait for children with cerebral palsy
Title of the study (Brief title)	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	Koji Ohata
Organization	Graduate school of Medicine, Kyoto University
Division name	Department of Human Health Sciences
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	Koji Ohata
Organization	Graduate school of Medicine, Kyoto University
Division name	Department of Human Health Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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