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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030594
Receipt No. 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 2019/02/28

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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
Institute Department of Rehabilitation Medicine, Keio University School of Medicine
Institute
Department

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 Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 05 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 12 Month 27 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.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


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