UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030594
Receipt number R000034926
Scientific Title Combined effect of motor imagery and peripheral nerve electrical stimulation in patients with stroke: single-blind random control trial
Date of disclosure of the study information 2018/01/01
Last modified on 2023/08/01 22:13:45

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Basic information

Public title

Combined effect of motor imagery and peripheral nerve electrical stimulation in patients with stroke: single-blind random control trial

Acronym

Effect of motor imagery and peripheral nerve electrical stimulation: RCT study

Scientific Title

Combined effect of motor imagery and peripheral nerve electrical stimulation in patients with stroke: single-blind random control trial

Scientific Title:Acronym

Effect of motor imagery and peripheral nerve electrical stimulation: RCT study

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Neurology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to elucidate the effect of combination peripheral nerve electrical stimulation and motor imagery on the functional recovery in stroke patients by single-blind randomized control trial.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II,III


Assessment

Primary outcomes

Fugl-Meyer assessment, Surface EMG of the extensor digitorum communis muscle and the flexor digitorum superficialis.

Key secondary outcomes

Reciprocal inhibition between flexor muscle and extensor muscle, Wolf Motor Function Test, Modified Ashworth Scale, Motor Activity Log, Range of Motion of finger joint (active and passive).


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Combination motor imagery and peripheral nerve electrical stimulation for 7 days

Interventions/Control_2

Motor imagery training for 7 days

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Stroke patients with hemiparesis;
more than 150 days had passed since stroke;
no cognitive deficits;
passive extension range of motion
(ROM) greater than -30 degrees for the affected MP joint;
Finger test score on Stroke Impairment Assessment Set is 1A

Key exclusion criteria

Severe heart disease;
Severe hypertension;
Acute fever;
Severe renal failure;
Severe liver disease;
History of major psychiatric or previous
neurological diseases, including seizures;
Apraxia of paretic finger;
Cardiac pacemaker

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michiyuki Kawakami

Organization

Keio university School of Medicine

Division name

Drepartment of Rehabilitation Medicine

Zip code


Address

35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan

TEL

03-5363-3833

Email

michiyukikawakami@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Michiyuki Kawakami

Organization

Keio university School of Medicine

Division name

Drepartment of Rehabilitation Medicine

Zip code


Address

35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan

TEL

03-5363-3833

Homepage URL


Email

michiyukikawakami@hotmail.com


Sponsor or person

Institute

Department of Rehabilitation Medicine, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

2018 Year 01 Month 01 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 01 Month 05 Day

Date of IRB

2018 Year 01 Month 05 Day

Anticipated trial start date

2018 Year 01 Month 05 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 12 Month 27 Day

Last modified on

2023 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034926


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name