UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026253 |
|---|---|
| Receipt number | R000030150 |
| Scientific Title | Clinical application of neuromuscular electrical stimulation therapy for Locomotive syndrome. |
| Date of disclosure of the study information | 2017/02/21 |
| Last modified on | 2020/11/20 08:56:20 |
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Basic information
Public title
Clinical application of neuromuscular electrical stimulation therapy for Locomotive syndrome.
Acronym
Clinical application of EMS for Locomotive syndrom
Scientific Title
Clinical application of neuromuscular electrical stimulation therapy for Locomotive syndrome.
Scientific Title:Acronym
Clinical application of EMS for Locomotive syndrom
Region
| Japan |
Condition
Condition
Locomotive syndrom
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to examine the effect of EMS for physical function and motor unit recruitment in locomotive syndrome patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurement of lower muscle strength is examine using the BIODEX system. Measurement is baseline, after 4 weeks, and 8 weeks.
Key secondary outcomes
Secondary outcomes are muscle thickness, balance performance, and motor unit recruitment.
Measurement of muscle thickness is examine using the ultrasound. Measurement of balance performance is examine using the Berg balance scale. Measurement of motor unit recruitment is examine using the multi-channel surface electromyography.
Measurement is baseline, after 4 weeks, and 8 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical muscle stimulation is perform 23 min/day, 3 days/week for 12 weeks. Rehabilitation is perform 1 day per week for 20 min.
Interventions/Control_2
Rehabilitation is perform 1 day per week for 20 min. Electrical muscle stimulation is not perform.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1: 65 < years old
2: Locomo degree 1 <
Key exclusion criteria
1: diabetes mellitus
2: neuromuscular disorders
3: hypersensitivity of alcohol
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kimura |
Organization
Hiroshima University Hospital
Division name
Rehabilitation Medicine
Zip code
734-8551
Address
1-2-3 Kasumi Minamiku Hiroshima-shi
TEL
082-257-5566
luna@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Nishikawa |
Organization
Hiroshima University
Division name
Department of Clinical Neuroscience and Therapeutics
Zip code
734-8551
Address
1-2-3 Kasumi Minamiku Hiroshima-shi
TEL
082-257-5201
Homepage URL
yuichi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University hospital IRB
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
082-257-5596
hugcp@hiroshima-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 21 | 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
29
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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 21 | Day |
Last modified on
| 2020 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030150
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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