UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021648 |
|---|---|
| Receipt number | 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 | 2020/04/03 21:27:06 |
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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
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
reha-oya@syutaikai.jp
Sponsor or person
Institute
Oyamada Memorial Hot Springs hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024964
