Unique ID issued by UMIN | UMIN000035798 |
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Receipt number | R000038525 |
Scientific Title | A randomized open-labeled crossover study of belt electrode skeletal muscle electrical stimulation system in hemophilia patients. |
Date of disclosure of the study information | 2019/02/08 |
Last modified on | 2023/02/13 11:54:37 |
A randomized open-labeled crossover study of belt electrode skeletal muscle electrical stimulation system in hemophilia patients.
A randomized open-labeled crossover study of belt electrode skeletal muscle electrical stimulation system in hemophilia patients.
A randomized open-labeled crossover study of belt electrode skeletal muscle electrical stimulation system in hemophilia patients.
A randomized open-labeled crossover study of belt electrode skeletal muscle electrical stimulation system in hemophilia patients.
Japan |
hemophilia
Rehabilitation medicine |
Others
NO
To clarify whether lower limb muscle strength, lower limb muscle mass and walking ability will improve by using B - SES at home as a home exercise for haemophilia patients.
Others
We analyze the relationship between the cumulative time of B-SES and muscular strength / muscle mass / walking ability.
Also, we examine the residual effect of B - SES by comparing muscular strength, muscle mass and walking ability after completion of B - SES in group A, after washout period and after control period.
Confirmatory
Pragmatic
Not applicable
*Muscle strength:hip abdution, knee extention, knee flextion
*Muscle mass:gluteus, quadriceps, hamstrings
*10m max speed, Timed Up and Go
*pain: VAS
We analyze the relationship between the cumulative time of B-SES and muscular strength / muscle mass / walking ability.
Also, we examine the residual effect of B - SES by comparing muscular strength, muscle mass and walking ability after completion of B - SES in group A, after washout period and after control period.
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
No treatment
NO
NO
Institution is considered as a block.
NO
Central registration
2
Educational,Counseling,Training
Other |
8 weeks B-SES,8 weeks wash-out,8 weeks no treatment
8 weeks no treatment,8 weeks wash-out,8 weeks B-SES
20 | years-old | <= |
70 | years-old | >= |
Male and Female
*Those who gained written consent regarding participation in research
*20 years or older
*hemophilia
*Bleeding tendency is controlled
*Free hand walking and cane walking
*pacemaker, implantable defibrillator
*inhibitor value is 5 BU / ML or more
*sensory disorder(abdomen, thighs)
*cancer
*Those who have judged that the research director is inappropriate for inclusion in research
12
1st name | Junko |
Middle name | |
Last name | Fujitani |
National Center for Global Health and Medicine
department of rehabilitation medicine
162-8655
1-21-1 Toyama, Shinjuku-ku, Tokyo
0332027181
jufujita@hosp.ncgm.go.jp
1st name | Junko |
Middle name | |
Last name | Fujitani |
National Center for Global Health and Medicine
department of rehabilitation medicine
162-8655
1-21-1 Toyama, Shinjuku-ku, Tokyo
0332027181
junkofujitani@hosp.ncgm.go.jp
National Center for Global Health and Medicine
Grant-in-Aid for Scientific Research(Ministry of Health, Labor and Welfare)
Japanese Governmental office
Japan
National Center for Global Health and Medicine
1-21-1, Shinjuku-ku, Tokyo
0332027181
jufujita@hosp.ncgm.go.jp
NO
国際医療研究センター
2019 | Year | 02 | Month | 08 | Day |
Published
https://kyusai.acc.go.jp/accrepo/longterm_treatment_r3.html
12
There was no significant difference in muscle strength, muscle mass, walking speed, or TUG between the B-SES intervention period and the non-intervention period. However, muscle strength and walking speed tended to be maintained and improved during the intervention period. A significant decrease in gluteus medius muscle mass was observed during the non-intervention period.
2023 | Year | 02 | Month | 13 | Day |
2022 | Year | 03 | Month | 31 | Day |
hemophilia patients with HIV infection due to contaminated blood products
After obtaining consent to participate in the study, the 12 participants were randomly assigned to groups A and B. Group A used B-SES for the first 8 weeks, followed by an 8-week washout period and an additional 8-week non-intervention period.
Group B had an initial 8-week no-intervention period followed by an 8-week washout period, followed by 8 weeks of B-SES.
None
*Hip joint abductor muscle strength
*Knee extension muscle strength
*Knee joint flexion muscle strength
*Gluteus medius muscle mass
*Quadriceps muscle mass
*Hamstring muscle mass
*10m maximum walking speed
*TUG
under consideration
under consideration
Completed
2018 | Year | 10 | Month | 29 | Day |
2018 | Year | 10 | Month | 29 | Day |
2018 | Year | 10 | Month | 29 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
Registration of 12 target cases has been
completed. Currently under research.
2019 | Year | 02 | Month | 07 | Day |
2023 | Year | 02 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038525
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