UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Developement of Integrated Volitional Control Electrical Stimulator(IVES) and its therapeutic effects in patients with stroke.
Title of the study (Brief title)	Developement of Integrated Volitional Control Electrical Stimulator(IVES) and its therapeutic effects in patients with stroke.
Region	Japan

Condition
Condition	Healthy subjests, Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Developement of Integrated Volitional control Electrical Stimulator (IVES) and its therapeutic effects in patients with stroke.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stroke Impairment Assessment Set(SIAS),Fugl-Meyer Assessment, Action Research Arm Test
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Integrated Volitional control Electrical Stimulator(IVES) and Prosthesis
Interventions/Control_2	Only Prosthesis
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	80 years-old >=
Gender	Male
Key inclusion criteria	First Attack of Stroke, Affected finger paresis is lower than 2 classified by Stroke Impairment Assessment Set.
Key exclusion criteria	Episode of epilepsy, Cogniive Deficits difficult to understand the study, Metalic something in body
Target sample size	20

Research contact person
Name of lead principal investigator	Keiichiro Shindo
Organization	Tokyo Metropolitan Rehabilitation Hospital
Division name	Department of rehabilitation medicine
Address	2-14-1, Tsutsumi do-ri, Sumida-ku, Tokyo
TEL
Email

Public contact
Name of contact person
Organization	Tokyo Metropolitan Rehabilitation Hospital
Division name	Department of rehabilitation medicine
Address
TEL
Homepage URL
Email	kshindo@tokyo-reha.jp

Sponsor
Institute	Department of Rehabilitation Medicine, Tokyo Metropolitan Rehabilitation Hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Rehabilitation Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2009 Year 05 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 07 Month 01 Day
Anticipated trial start date	2007 Year 07 Month 01 Day
Last follow-up date	2009 Year 07 Month 01 Day
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	https://journals.sagepub.com/doi/full/10.1177/1545968311408917?url_ver=Z39.88-2003&rfr_id=ori%3Arid%
Results
Other related information

Management information
Registered date	2009 Year 05 Month 14 Day
Last modified on	2019 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002404