UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012879
Receipt number R000015036
Scientific Title the effects of Stride Management Assist Device for patients after stroke in sub-acute phase.
Date of disclosure of the study information 2014/01/20
Last modified on 2016/02/04 18:19:59

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Basic information

Public title

the effects of Stride Management Assist Device for patients after stroke in sub-acute phase.

Acronym

the effects of Stride Management Assist Device

Scientific Title

the effects of Stride Management Assist Device for patients after stroke in sub-acute phase.

Scientific Title:Acronym

the effects of Stride Management Assist Device

Region

Japan


Condition

Condition

patients after stroke in sub-acute phase

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify the effects of robot -assisted gait training with new device named Stride Management Assist Device (SMAD) on kinematic, kinetic gait parameters, muscle activities during walking, and motor function in individuals after stroke.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Gait Analysis: peak joint angles and joint moments during walking.
Gait EMG analysis: muscle activity at Tibialis anterior, Gastrocmemius , and Soleus.

Key secondary outcomes

Brunnstrom stage(BRS), Barthal Index(BI), Functional Ambulation Category(FAC), Modified Ashworth Scale(MAS), 10m walk test(TWT), Timed Up and Go(TUG), Muscle strength of hip knee ankle joints, Short Form of the Berg Balance Scale(SFBBS), Functional Reach Test(FRT), Activities specific Balance Confidence scale(ABC), and Trunk Impairment Scale(TIS).


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

group A received regular physiotherapy for 20 minutes and gait training with SMAD for 20 minutes each workday 5 times a week for 4 weeks. Then, without wash-out phase, this group eceived regular physiotherapy for 20 minutes and gait training without SMAD for 20 minutes each workday 5 times a week for 4 weeks.

Interventions/Control_2

group B received regular physiotherapy for 20 minutes and gait training without SMAD for 20 minutes each workday 5 times a week for 4 weeks. Then, without wash-out phase, this group eceived regular physiotherapy for 20 minutes and gait training with SMAD for 20 minutes each workday 5 times a week for 4 weeks.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients aged more than 20 years old and who are allowed to participate the study by the attending physician.
Time since stroke onset <3 months
Ability to ambulate 10meters independently without brace
Cognitive ability to understand the explanation of the study and to follow the training instructions.

Key exclusion criteria

Bilateral stroke or stroke of the brainstem.
Severe cardiac or heart disease to limit the activity.
Severe orthopedic disease limiting walking in the spine or lower extremities.

Target sample size

23


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koji Ohata

Organization

Graduate school of Medicine, Kyoto University

Division name

Department of Human Health Sciences

Zip code


Address

53 Kawaharacho, Shogoin, Sakyo-ku, Kyoto city, Kyoto, Japan

TEL

075-751-3918

Email

ohata.koji.7n@kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koji Ohata

Organization

Graduate school of Medicine, Kyoto University

Division name

Department of Human Health Sciences

Zip code


Address

53 Kawaharacho, Shogoin, Sakyo-ku, Kyoto city, Kyoto, Japan

TEL

075-751-3918

Homepage URL


Email

ohata.koji.7n@kyoto-u.ac.jp


Sponsor or person

Institute

Department of Human Health Sciences, Graduate school of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Honda R&D Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

湯布院厚生年金病院


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Main results already published

Date of protocol fixation

2014 Year 01 Month 20 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 01 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 16 Day

Last modified on

2016 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015036


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name