UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of belt electrode skeletal muscle electrical stimulation (B-SES) on disabled elderly patients with serious limitation of range of motion.
Title of the study (Brief title)	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	Hideki Katoaka
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Locomotive Rehabilitation Science
Address	1-7-1 Sakamoto Nagasaki, Japan
TEL	095-819-7919
Email	kataoka-hide@kii.bbiq.jp

Public contact
Name of contact person	Hideki Katoaka
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Locomotive Rehabilitation Science
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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