UMIN-CTR Clinical Trial

Basic information
Public title	Body Weight Support treadmill with using robot suit HAL Effect on respiratory circulation and metabolic function during walking
Acronym	Body Weight Support treadmill with using robot suit HAL Effect on respiratory circulation and metabolic function during walking
Scientific Title	Body Weight Support treadmill with using robot suit HAL Effect on respiratory circulation and metabolic function during walking
Scientific Title:Acronym	Body Weight Support treadmill with using robot suit HAL Effect on respiratory circulation and metabolic function during walking
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine a walking practice program for healthy adults from the viewpoint of respiratory, circulatory and metabolic function during unloaded walking using a robot suit HAL.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Oxygen consumption, Heart rate, blood pressure, Respiratory function, etc
Key secondary outcomes	Mets, Mets

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	non weight partial weight
Interventions/Control_2	body Weight Support treadmill walking(BWSST) 5 min Cardiopulmonary Exercise Training
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	20 years-old <=
Age-upper limit	24 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adults with free will consent
Key exclusion criteria	Persons with medical or orthopedic diseases. Those who have offered to decline participation in this research or withdrew their consent. Those who cannot carry out all the inspection tasks.
Target sample size	11

Research contact person
Name of lead principal investigator	1st name isao Middle name Last name ojima
Organization	Faculty of Rehabilitation, Kobe gakuin university
Division name	department of physical therapy
Zip code	6512180
Address	518 arise, ikawadani-cho, nishi-ku Kobe, 651-2180
TEL	078-974-2198
Email	ojima@reha.kobegakuin.ac.jp

Public contact
Name of contact person	1st name isao Middle name Last name ojima
Organization	kobe gakuin university
Division name	faculty of rehabilitation
Zip code	651-2276
Address	518 arise, ikawadani-cho, nishi-ku Kobe, 651-2180
TEL	09087563844
Homepage URL
Email	ojima@reha.kobegakuin.ac.jp

Sponsor
Institute	kobe gakuin university faculty of rehabilitation
Institute
Department

Funding Source
Organization	kobe gakuin university faculty of rehabilitation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	kobe gakuin university
Address	518 arise, ikawadani-cho, nishi-ku Kobe, 651-2180
Tel	0789742198
Email	ojima@reha.kobegakuin.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	2022 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Preinitiation
Date of protocol fixation	2022 Year 03 Month 23 Day
Date of IRB	2022 Year 04 Month 25 Day
Anticipated trial start date	2022 Year 05 Month 01 Day
Last follow-up date	2022 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 05 Month 12 Day
Last modified on	2022 Year 05 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053900