UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000015438
Receipt number	R000014754
Scientific Title	Clinical trial of combined therapy using robot-assisted arm training(AT) with transcranial direct current stimulation(tDCS) or transcranial magnetic stimulation(TMS) for impairment of the upper limb in chronic post-stroke patients.
Date of disclosure of the study information	2014/10/16
Last modified on	2014/10/15 17:39:01

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Basic information

Public title

Clinical trial of combined therapy using robot-assisted arm training(AT) with transcranial direct current stimulation(tDCS) or transcranial magnetic stimulation(TMS) for impairment of the upper limb in chronic post-stroke patients.

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Assessment

Primary outcomes

(Outcome measurement)
<Impairment Assesment of U/E>
1.Brunnstrom stage:U/E
2.Stroke Impairment Assessment Set(SIAS):knee-mouth test, finger-function test
3.Fugl-Meyer Assesment(FMA):U/E
4.STEF: All items
5.Wolf Motor Function Test(WMFT): All items
6.Modified Ashworth Scale(MAS):Elbow flexor and extensor, Spinator, Pronator, Wrist flexor and extensor, Finger flexor and extensor
7.Range of motion(ROM): Shoulder, Elbow, Arm, and Wrist
<Functional assessment of U/E>
1.Mo tor Activity Log(MAL): 14 items
<Others>
1.Stroke impact scale(SIS)
2.Visual Analogue Scale(VAS): Degree of satisfaction

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Seven days intervention.
Anodal tDCS(2mA) to the affected hemisphere with AT for 20min.
Standard rehabilitation session for upper extremity by OT .

Interventions/Control_2

Seven days intervention.
repetitive transcranial magnetic stimulation(rTMS) to the non affected hemisphere with AT.
Standard rehabilitation session for upper extremity by OT .

Interventions/Control_3

Seven days intervention.
Sham tDCS(the current turn on for only 5 second) to the affected hemisphere with AT for 20min.
Standard rehabilitation session for upper extremity by OT .

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with post-stroke hemiplegia
First stroke occurred more than 6 months before the study

Key exclusion criteria

Previous stroke
Preceding epilepsy
Severe cognitive impairments
Serious cardiac or orthopaedic problems
Metallic implants within the brain

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Hideaki Itoh

Organization

University of Environmental Health

Division name

Department of Rehabiliration medicine, School of Medicine

Zip code

Address

1-1 Iseigaoka, Yahatanishi-Ku, Kitakyusyu807-8555, Fukuoka, Japan

TEL

093-603-1611

Email

hide-ito@med.uoeh-u.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Hideaki Itoh

Organization

University of Environmental Health

Division name

Department of Rehabiliration medicine, School of Medicine

Zip code

Address

1-1 Iseigaoka, Yahatanishi-Ku, Kitakyusyu807-8555, Fukuoka, Japan

TEL

093-603-1611

Homepage URL

Email

hide-ito@med.uoeh-u.ac.jp

Sponsor or person

Institute

University of Environmental Health
Department of Rehabiliration medicine, School of Medicine

Institute

Department

Personal name

Funding Source

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

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 16 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

Open public recruiting

Date of protocol fixation

2014 Year 07 Month 07 Day

Date of IRB

Anticipated trial start date

2014 Year 10 Month 16 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

2014 Year 10 Month 15 Day

Last modified on

2014 Year 10 Month 15 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014754

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name