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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026808
Receipt No. R000030779
Scientific Title Effects of belt electrode skeletal muscle electrical stimulation (B-SES) on disabled elderly patients with serious limitation of range of motion.
Date of disclosure of the study information 2017/04/10
Last modified on 2017/03/31

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Basic information
Public title Effects of belt electrode skeletal muscle electrical stimulation (B-SES) on disabled elderly patients with serious limitation of range of motion.
Acronym Effects of B-SES on serious limitation of range of motion.
Scientific Title Effects of belt electrode skeletal muscle electrical stimulation (B-SES) on disabled elderly patients with serious limitation of range of motion.
Scientific Title:Acronym Effects of B-SES on serious limitation of range of motion.
Region
Japan

Condition
Condition stroke, spinal cord injury, degenerative disease
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of B-SES on range of motion and muscle tone, and pain of disabled elderly patients with serious limitation of range of motion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Range of motion of lower limbs at baseline, and 1, 2, 3 months after strat of tretment
Key secondary outcomes Muscle tone and Pain

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In addition to rehabilitation mainly consisted with ROMex and sitting or standing, B-SES is applied on bilateral lower limbs 3 times per week for 3 months.
Interventions/Control_2 Rehabilitation mainly consisted with ROMex and sitting or standing.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Bedridden disabled elderly patients
Key exclusion criteria 1) patients who cannot be applied electrical stimulation
2) patients who do not agree to this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Katoaka
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Locomotive Rehabilitation Science
Zip code
Address 1-7-1 Sakamoto Nagasaki, Japan
TEL 095-819-7919
Email kataoka-hide@kii.bbiq.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Katoaka
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Locomotive Rehabilitation Science
Zip code
Address 1-7-1 Sakamoto Nagasaki, Japan
TEL 095-819-7919
Homepage URL
Email kataoka-hide@kii.bbiq.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 31 Day
Last modified on
2017 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030779

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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