UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026808
Receipt number 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 18:55:13

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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 or person

Institute

Nagasaki University Graduate School of Biomedical Sciences

Institute

Department

Personal name



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

Value
https://center6.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