UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012361
Receipt number R000014370
Scientific Title Effects of weight-bearing training with plantar perceptual learning in stroke patients
Date of disclosure of the study information 2013/11/20
Last modified on 2014/11/20 15:02:00

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Basic information

Public title

Effects of weight-bearing training with plantar perceptual learning in stroke patients

Acronym

Effects of weight-bearing training with plantar perceptual learning in stroke patients

Scientific Title

Effects of weight-bearing training with plantar perceptual learning in stroke patients

Scientific Title:Acronym

Effects of weight-bearing training with plantar perceptual learning in stroke patients

Region

Japan


Condition

Condition

Stroke patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was the influence of the perceptual training of weight-bearing rate of the lower limbs in stroke patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Body sway test
Weight-bearing rate of the lower limbs
10m walking test

Key secondary outcomes

2 point discrimination test
Functional reach test
Trail Making Test PartA or PartB
Balance efficacy test


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The group of discrimination of sponge rubber by foot sole.

Interventions/Control_2

The group of non discrimination of sponge rubber by foot sole.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

can maintain a standing position independently

Key exclusion criteria

a higher brain function disorder

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Fujita

Organization

Kio University

Division name

Graduate School of Health Science

Zip code


Address

4-2-2Umami-naka, Koryo-tyo, Kitakatsuragi-gun, Nara

TEL

0745-54-1602

Email

hiyoyuki0010@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Fujita

Organization

Kio University

Division name

Graduate School of Health Science

Zip code


Address

4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara

TEL

0745-54-1602

Homepage URL


Email

hiyoyuki0010@yahoo.co.jp


Sponsor or person

Institute

Kio University

Institute

Department

Personal name



Funding Source

Organization

Kio University

Organization

Division

Category of Funding 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

平成記念病院(奈良県)、東大阪山路病院(大阪府)、アクアクリニック伊賀(三重県)
リハビリあえる(奈良県)


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 20 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

2013 Year 09 Month 17 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 28 Day

Last follow-up date

2014 Year 04 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 11 Month 20 Day

Last modified on

2014 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014370


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name