UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Combined effect of motor imagery and peripheral nerve electrical stimulation in patients with stroke.
Title of the study (Brief title)	Effect of motor imagery and peripheral nerve electrical stimulation
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 was to elucidate the effect of combination peripheral nerve electrical stimulation and motor imagery on the functional recovery in stroke patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Surface EMG of the extensor digitorum communis muscle and the flexor digitorum superficialis.
Key secondary outcomes	Reciprocal inhibition between flexor muscle and extensor muscle, Fugl-Meyer test, Stroke Impairment Assessment Set, Modified Ashworth Scale

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Combintion motor imagery and peripheral nerve electrical stimulation
Interventions/Control_2
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	12 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; No EMG activity on the EDC muscle or the FDS muscle
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	20

Research contact person
Name of lead principal investigator	Michiyuki Kawakami
Organization	Keio university School of Medicine
Division name	Drepartment of Rehabilitation Medicine
Address	35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL	03-5363-3833
Email	michiyukikawakami@hotmail.com

Public contact
Name of contact person	Michiyuki Kawakami
Organization	Keio university School of Medicine
Division name	Drepartment of Rehabilitation Medicine
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	Japan Science and Technology and Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	2016 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 23 Day
Last modified on	2018 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027332