UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035798
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

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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 or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



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

Published


Result

URL related to results and publications

https://kyusai.acc.go.jp/accrepo/longterm_treatment_r3.html

Number of participants that the trial has enrolled

12

Results

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.

Results date posted

2023 Year 02 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 03 Month 31 Day

Baseline Characteristics

hemophilia patients with HIV infection due to contaminated blood products

Participant flow

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.

Adverse events

None

Outcome measures

*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

Plan to share IPD

under consideration

IPD sharing Plan description

under consideration


Progress

Recruitment status

Completed

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

Registration of 12 target cases has been
completed. Currently under research.


Management information

Registered date

2019 Year 02 Month 07 Day

Last modified on

2023 Year 02 Month 13 Day



Link to view the page

Value
https://center6.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