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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035798
Receipt No. 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 2019/09/12

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Basic information
Public title A randomized open-labeled crossover study of belt electrode skeletal muscle electrical stimulation system in hemophilia patients.
Acronym A randomized open-labeled crossover study of belt electrode skeletal muscle electrical stimulation system in hemophilia patients.
Scientific Title A randomized open-labeled crossover study of belt electrode skeletal muscle electrical stimulation system in hemophilia patients.
Scientific Title:Acronym A randomized open-labeled crossover study of belt electrode skeletal muscle electrical stimulation system in hemophilia patients.
Region
Japan

Condition
Condition hemophilia
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Others
Basic objectives -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.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes *Muscle strength:hip abdution, knee extention, knee flextion
*Muscle mass:gluteus, quadriceps, hamstrings
*10m max speed, Timed Up and Go
*pain: VAS
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 8 weeks B-SES,8 weeks wash-out,8 weeks no treatment
Interventions/Control_2 8 weeks no treatment,8 weeks wash-out,8 weeks B-SES
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
70 years-old >=
Gender Male and Female
Key inclusion criteria *Those who gained written consent regarding participation in research
*20 years or older
*hemophilia
*Bleeding tendency is controlled
*Free hand walking and cane walking
Key exclusion criteria *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
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Junko
Middle name
Last name Fujitani
Organization National Center for Global Health and Medicine
Division name department of rehabilitation medicine
Zip code 162-8655
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL 0332027181
Email jufujita@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Junko
Middle name
Last name Fujitani
Organization National Center for Global Health and Medicine
Division name department of rehabilitation medicine
Zip code 162-8655
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL 0332027181
Homepage URL
Email junkofujitani@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research(Ministry of Health, Labor and Welfare)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center for Global Health and Medicine
Address 1-21-1, Shinjuku-ku, Tokyo
Tel 0332027181
Email jufujita@hosp.ncgm.go.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 国際医療研究センター

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 08 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 No longer recruiting
Date of protocol fixation
2018 Year 10 Month 29 Day
Date of IRB
2018 Year 10 Month 29 Day
Anticipated trial start date
2018 Year 10 Month 29 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 03 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 02 Month 07 Day
Last modified on
2019 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038525

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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