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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021648
Receipt No. R000024964
Scientific Title Use effect of walking support machine ACSIVE for our hospital inpatient, outpatient
Date of disclosure of the study information 2016/03/28
Last modified on 2019/03/31

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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 Enrolling by invitation
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
2019 Year 03 Month 31 Day


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

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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