Unique ID issued by UMIN | UMIN000043683 |
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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 | 2024/04/25 09:20:42 |
To investigate whether the use of SIXPAD in patients with arteriosclerosis obliterans contributes to the strengthening of lower limb muscles.
Evaluation of the effect of SIXPAD on lower limb muscle strength in arteriosclerosis obliterans
Evaluation of the effect of SIXPAD on lower limb muscle strength in patients with arteriosclerosis obliterans
Effect of SIXPAD on lower limb muscle strength in patients with ASO
Japan |
arteriosclerosis obliterans
Cardiology | Vascular surgery |
Others
NO
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.
Efficacy
Confirmatory
Lower leg muscle strength, plantar muscle strength, gastrocnemius muscle thickness, muscle mass
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
24 weeks
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
30
1st name | Shinobu |
Middle name | |
Last name | Ayabe |
Yao Tokushukai General Hospital
Plastic surgery
5810011
1-17, Wakakusa-cho, Yao-city, Osaka
072-993-8501
ayabeshinobu@gmail.com
1st name | Shinobu |
Middle name | |
Last name | Ayabe |
Yao Tokushukai General Hospital
Plastic surgery
5810011
1-17, Wakakusa-cho, Yao-city, Osaka
072-993-8501
ayabeshinobu@gmail.com
Yao Tokushukai General Hospital
Yao Tokushuka General Hospital
Self funding
The Tokushukai Group Ethics Committee
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan
03-3263-4801
mirai-ec1@mirai-iryo.com
NO
2021 | Year | 04 | Month | 07 | Day |
Unpublished
Completed
2021 | Year | 04 | Month | 07 | Day |
2021 | Year | 04 | Month | 15 | Day |
2021 | Year | 04 | Month | 15 | Day |
2023 | Year | 04 | Month | 07 | Day |
2021 | Year | 03 | Month | 20 | Day |
2024 | Year | 04 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049849
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