UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031957
Receipt number R000036495
Scientific Title Prevention of shoulder subluxation in stroke patients with magnetic stimulation: A randomized controlled trial
Date of disclosure of the study information 2018/03/29
Last modified on 2023/04/20 00:15:03

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Basic information

Public title

Prevention of shoulder subluxation in stroke patients with magnetic stimulation: A randomized controlled trial

Acronym

A randomized controlled trial for prevention of shoulder subluxation with magnetic stimulation

Scientific Title

Prevention of shoulder subluxation in stroke patients with magnetic stimulation: A randomized controlled trial

Scientific Title:Acronym

A randomized controlled trial for prevention of shoulder subluxation with magnetic stimulation

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of prevention for shoulder subluxation in stroke patients with magnetic stimulation to shoulder muscles

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in humeral head position by X-ray examination after 6-week intervention

Key secondary outcomes

Changes in motor function, joint range of motion, muscle strength, and pain


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Six weeks magnetic stimulation in addition to usual training: 20 minutes stimulation per day, 5 days per week plus physical therapy and occupational therapy

Interventions/Control_2

Six weeks conventional training: usual physical therapy and occupational therapy

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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with hemiplegia after stroke with stable general condition, and aged 20 or older who gave informed consent

Key exclusion criteria

Patients with unstable general condition, history of epilepsy, cardiac pacemaker, difficulty in sitting position over 40 minutes, had magnetic materials near the stimulation site, inpatients who are expected to discharge within 6 weeks and pregnant women. Patients whose distance between acromion and humeral head are more than 1/2 finger-breadth are also excluded.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Eiichi
Middle name
Last name Saitoh

Organization

Fujita Health University

Division name

Department of Rehabilitation Medicine I, School of Medicine

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan

TEL

0562-93-2167

Email

rehabmed@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Kenta
Middle name
Last name Fujimura

Organization

Fujita Health University

Division name

Faculty of Rehabilitation, School of Health Sciences

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan

TEL

0562-93-9000

Homepage URL


Email

rehabmed@fujita-hu.ac.jp


Sponsor or person

Institute

Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fujita Health University

Address

1-98 Dengakugakubo, Kutsukake, Toyoake

Tel

0562-93-9000

Email

rehabmed@fujita-hu.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

2018 Year 03 Month 29 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


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

2018 Year 03 Month 29 Day

Date of IRB

2018 Year 03 Month 30 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2022 Year 02 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 29 Day

Last modified on

2023 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036495


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name