UMIN-CTR Clinical Trial

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
Email	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
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	Ethics Committee Graduate School and Faculty of Medicine Kyoto University
Address	54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto city, Kyoto, Japan
Tel	075-753-4680
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050096