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

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 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

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

Value
https://center6.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