UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028576
Receipt number R000032624
Scientific Title Effects of a hip extension movement assist on the gait of stroke using a walking assist device ACSIVE
Date of disclosure of the study information 2017/09/01
Last modified on 2019/08/13 09:57:56

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Basic information

Public title

Effects of a hip extension movement assist on the gait of stroke using a walking assist device ACSIVE

Acronym

Effects of a hip extension movement assist on the gait of stroke

Scientific Title

Effects of a hip extension movement assist on the gait of stroke using a walking assist device ACSIVE

Scientific Title:Acronym

Effects of a hip extension movement assist on the gait of stroke

Region

Japan


Condition

Condition

Cerebrovascular disease

Classification by specialty

Neurology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze the influence on hip flexion moment by implementing the hip joint extension movement assist on the affected side in stance phase to stroke patients with ACSIVE walking support equipment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Hip joint moment with or without ACSIVE during gait.

Key secondary outcomes

Hip joint angle with or without ACSIVE during gait.


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

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Put the marker on the shoulder, pelvis, and joint of the lower limbs on both side and walk with the walking course with the floor reaction force gauge with comfortable walking speed with or without ACSIVE. Measure the state of walking simultaneously with four video cameras. The required time is about 45 minutes.

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Users of Nagoya city Rehabilitation center with ability to walk independently in indoors.

Key exclusion criteria

Those who can not understand the explanation of the research by reason of severe cognitive impairment.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Masaki
Middle name
Last name Ishiguro

Organization

Nagoya City Rehabilitation Agency

Division name

Division of Physical Therapy

Zip code

4678622

Address

1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan

TEL

052-835-3811

Email

Physical@nagoya-rehab.or.jp


Public contact

Name of contact person

1st name Masaki
Middle name
Last name Ishiguro

Organization

Nagoya City Rehabilitation Agency

Division name

Division of Physical Therapy

Zip code

467-8622

Address

1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan

TEL

052-835-3811

Homepage URL


Email

Physical@nagoya-rehab.or.jp


Sponsor or person

Institute

Nagoya City Rehabilitation Agency

Institute

Department

Personal name



Funding Source

Organization

no

Organization

Division

Category of Funding Organization

Self funding

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

Nagoya City Rehabilitation Agency

Address

1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan

Tel

052-835-3811

Email

soumubu@nagoya-rehab.or.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

2017 Year 09 Month 01 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

12

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

No longer recruiting

Date of protocol fixation

2017 Year 08 Month 01 Day

Date of IRB

2017 Year 10 Month 02 Day

Anticipated trial start date

2017 Year 10 Month 02 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 04 Month 10 Day

Date trial data considered complete

2019 Year 04 Month 10 Day

Date analysis concluded

2019 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 08 Month 08 Day

Last modified on

2019 Year 08 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032624


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name