UMIN-CTR Clinical Trial

Basic information
Public title	Use effect of walking support machine ACSIVE for our hospital inpatient, outpatient
Acronym	Use effect of ACSIVE
Scientific Title	Use effect of walking support machine ACSIVE for our hospital inpatient, outpatient
Scientific Title:Acronym	Use effect of ACSIVE
Region	Japan

Condition
Condition	Stroke,fracture
Classification by specialty	Neurology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We have a rehabilitation to patients who have suffered a stroke or bone fracture. Has decreased walking function therein, patients undergoing physical therapy interventions to improve its function as a purpose are numerous. 2014 September, generally sold announced the walking support machine ACSIVE is a walking support equipment to assist the square one of the legs to act is the movement of the pendulum and the spring without the use of electricity and motor. ACSIVE, the adaptation is hemiplegic patients and walking force is the weak elderly functional specific bodily functions such as muscle strength and paralysis as is the current situation is not presented. So with in this study to verify whether or not there is any change in the main and the body functions the walking function by performing a walking wearing the ACSIVE for patients with decreased walking function, a more detailed adaptation It aimed to clarify. Future in that it becomes clear, it is possible to achieve the means expansion of physical therapy intervention for the purpose of walking ability improvement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	ACSIVE mounted before,ACSIVE during wear,ACSIVE after installation:Joint angle during walking.
Key secondary outcomes	The joint moment and the floor reaction force.Walking rate,walking speed.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	Time required about 30 minutes Carry out the shooting walking motion with four of the video camera. Worn before, when worn, carried out after each wearing. When walking is to measure the floor reaction force at the same time.
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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Ambulatory
Key exclusion criteria	Those who study can not understand. It is a strong pain.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Motoki Middle name Last name Yamanaka
Organization	Oyamada Memorial Hot Springs hospital
Division name	Rehabilitation center
Zip code	519-0163
Address	Kameyama, Mie Prefecture Kameda, Niigata 443-12
TEL	090-7049-0510
Email	quality_of_life_m@yahoo.co.jp

Public contact
Name of contact person	1st name Motoki Middle name Last name Yamanaka
Organization	Oyamada Memorial Hot Springs hospital
Division name	Rehabilitation center
Zip code	512-1111
Address	Yokkaichi, Mie Prefecture Yamada 5538-1
TEL	059-328-1260
Homepage URL
Email	reha-oya@syutaikai.jp

Sponsor
Institute	Oyamada Memorial Hot Springs hospital
Institute
Department

Funding Source
Organization	Suzuka University of Medical Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Suzuka University of Medical Science
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Oyamada Memorial Hot Springs hospital
Address	Yokkaichi, Mie Prefecture Yamada 5538-1
Tel	0593281260
Email	reha-oya@syutaikai.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	小山田記念温泉病院(三重県)

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 28 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	2015 Year 12 Month 21 Day
Date of IRB	2015 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 03 Month 28 Day
Last follow-up date	2019 Year 12 Month 21 Day
Date of closure to data entry	2020 Year 12 Month 21 Day
Date trial data considered complete	2020 Year 12 Month 21 Day
Date analysis concluded	2021 Year 12 Month 21 Day

Other
Other related information

Management information
Registered date	2016 Year 03 Month 28 Day
Last modified on	2020 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024964