UMIN-CTR Clinical Trial

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
Email	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
Email	yuichi@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030150