UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034197
Receipt number R000038885
Scientific Title Immediate effect of orthotic therapy for patients with peripheral artery disease with intermittent claudication
Date of disclosure of the study information 2018/10/01
Last modified on 2018/11/13 11:59:15

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Basic information

Public title

Immediate effect of orthotic therapy for patients with peripheral artery disease with intermittent claudication

Acronym

Effect of orthotic therapy for patients with peripheral artery disease

Scientific Title

Immediate effect of orthotic therapy for patients with peripheral artery disease with intermittent claudication

Scientific Title:Acronym

Effect of orthotic therapy for patients with peripheral artery disease

Region

Japan


Condition

Condition

Peripheral arterial diseae

Classification by specialty

Vascular surgery Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the immediate effect of the orthosis therapy in patients with peripheral arterial disease with intermittent claudication

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Maximum walking distance in the 6-minutes walking test

Key secondary outcomes

Walking speed
Joint torque
Joint power


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

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Using the orthosis for patients with drop foot

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

Resting ankle-brachial index <0.9
Symptomatic intermittent claudication
Patients who can walk without assist device
Patients who can understand oral instruction

Key exclusion criteria

Patients with critical limb ischemia.
Patients with limitations to walking for reasons other than claudication such as pulmonary, cardiac, nervous, and musculoskeletal disease.

Target sample size

66


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Kohzuki

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Internal Medicine and Rehabilitation Science

Zip code


Address

2-1, Seiryo-cho, Aoba-ku, Sendai, Japan

TEL

022-717-7353

Email

kohzuki@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taakaaki Kakihana

Organization

Tohoku University Hospital

Division name

Department of Rehabilitation

Zip code


Address

1-1, Seiryo-cho, Aoba-ku, Sendai, Japan

TEL

022-717-7677

Homepage URL


Email

takaaki.kakihana.b8@tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Medicine Department of Internal Medicine and Rehabilitation Science

Institute

Department

Personal name



Funding Source

Organization

The Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

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

東北大学病院(宮城県)


Other administrative information

Date of disclosure of the study information

2018 Year 10 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


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

2019 Year 09 Month 05 Day

Date of IRB


Anticipated trial start date

2019 Year 09 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 19 Day

Last modified on

2018 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038885


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name