UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041929
Receipt number R000047851
Scientific Title Development of the improved the knee orthosis that prevents the inappropriate knee bending during the stance phase for various walking conditions
Date of disclosure of the study information 2020/09/30
Last modified on 2020/10/06 17:49:57

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Basic information

Public title

Development of the improved the knee orthosis that prevents the inappropriate knee bending during the stance phase for various walking conditions

Acronym

Development of the improved the knee orthosis that prevents the inappropriate knee bending during the stance phase

Scientific Title

Development of the improved the knee orthosis that prevents the inappropriate knee bending during the stance phase for various walking conditions

Scientific Title:Acronym

Development of the improved the knee orthosis that prevents the inappropriate knee bending during the stance phase

Region

Japan


Condition

Condition

Stroke patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the usefulness of an improved the knee orthosis that prevents the inappropriate knee bending during the stance phase

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

A subjective evaluation for an improved the knee orthosis that prevents the inappropriate knee bending during the stance phase

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The walking and climbing of stairs with the knee orthosis that prevents the knee bending during the stance phase

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with muscle weakness in knee extension due to hemiplegia caused by stroke

Key exclusion criteria

Unstable vital signs

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Yohei
Middle name
Last name Otaka

Organization

Fujita Health University

Division name

Department of Rehabilitation medicine I, School of medicine

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN

TEL

0562-93-2167

Email

rehabmed@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Makino

Organization

Fujita Health University

Division name

Department of Rehabilitation medicine I, School of medicine

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN

TEL

0562-93-2167

Homepage URL


Email

rehabmed@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

Toyota motor corporation

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

Fujita Health University Certified Clinical Research Review Board

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN

Tel

0562-93-2865

Email

f-irb@fujita-hu.ac.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

2020 Year 09 Month 30 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

Enrolling by invitation

Date of protocol fixation

2020 Year 06 Month 22 Day

Date of IRB

2020 Year 09 Month 28 Day

Anticipated trial start date

2020 Year 09 Month 30 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 09 Month 29 Day

Last modified on

2020 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047851


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name