UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043683
Receipt number R000049849
Scientific Title Evaluation of the effect of SIXPAD on lower limb muscle strength in patients with arteriosclerosis obliterans
Date of disclosure of the study information 2021/04/07
Last modified on 2022/03/22 17:33:02

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Basic information

Public title

To investigate whether the use of SIXPAD in patients with arteriosclerosis obliterans contributes to the strengthening of lower limb muscles.

Acronym

Evaluation of the effect of SIXPAD on lower limb muscle strength in arteriosclerosis obliterans

Scientific Title

Evaluation of the effect of SIXPAD on lower limb muscle strength in patients with arteriosclerosis obliterans

Scientific Title:Acronym

Effect of SIXPAD on lower limb muscle strength in patients with ASO

Region

Japan


Condition

Condition

arteriosclerosis obliterans

Classification by specialty

Cardiology Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Since the SIXPAD Foot Fit can be used to increase muscle strength without loading or walking, we will use the SIXPAD Foot Fit on "patients with arteriosclerosis obliterans" to evaluate whether it is effective in increasing muscle strength.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Lower leg muscle strength, plantar muscle strength, gastrocnemius muscle thickness, muscle mass

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

24 weeks

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

1) Patients with SPP of less than 50 mmHg
2) Patients aged 20 years or older at the time of consent (regardless of gender)
3) Patients who have given their free written consent to participate in this study after receiving sufficient explanation.
4) Outpatients or inpatients

Key exclusion criteria

1) Patients who have used the SIXPAD Foot Fit within one month prior to obtaining consent
2) Patients with an implantable medical electrical device such as a pacemaker
3) Patients using life-supporting medical electrical devices such as artificial heart lung
4) Patients with electrocardiographs or other wearable medical electrical devices
5) Patients who are pregnant or have just given birth
6) Patients with venous thrombosis
7) Patients with metal implants such as bolts in the area from the hip joint to the toes
8) Other patients who are judged by the principal investigator to be inappropriate as research subjects.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Shinobu
Middle name
Last name Ayabe

Organization

Yao Tokushukai General Hospital

Division name

Plastic surgery

Zip code

5810011

Address

1-17, Wakakusa-cho, Yao-city, Osaka

TEL

072-993-8501

Email

ayabeshinobu@gmail.com


Public contact

Name of contact person

1st name Shinobu
Middle name
Last name Ayabe

Organization

Yao Tokushukai General Hospital

Division name

Plastic surgery

Zip code

5810011

Address

1-17, Wakakusa-cho, Yao-city, Osaka

TEL

072-993-8501

Homepage URL


Email

ayabeshinobu@gmail.com


Sponsor or person

Institute

Yao Tokushukai General Hospital

Institute

Department

Personal name



Funding Source

Organization

Yao Tokushuka General Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Tokushukai Group Ethics Committee

Address

Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan

Tel

03-3263-4801

Email

mirai-ec1@mirai-iryo.com


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

2021 Year 04 Month 07 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

2021 Year 04 Month 07 Day

Date of IRB

2021 Year 04 Month 15 Day

Anticipated trial start date

2021 Year 04 Month 15 Day

Last follow-up date

2023 Year 04 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 03 Month 20 Day

Last modified on

2022 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049849


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name