UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001971
Receipt No. R000002404
Scientific Title Developement of Integrated Volitional Control Electrical Stimulator(IVES) and its therapeutic effects in patients with stroke.
Date of disclosure of the study information 2009/05/18
Last modified on 2019/03/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Developement of Integrated Volitional Control Electrical Stimulator(IVES) and its therapeutic effects in patients with stroke.
Acronym Developement of Integrated Volitional Control Electrical Stimulator(IVES) and its therapeutic effects in patients with stroke.
Scientific Title Developement of Integrated Volitional Control Electrical Stimulator(IVES) and its therapeutic effects in patients with stroke.
Scientific Title:Acronym 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
1st name
Middle name
Last name Keiichiro Shindo
Organization Tokyo Metropolitan Rehabilitation Hospital
Division name Department of rehabilitation medicine
Zip code
Address 2-14-1, Tsutsumi do-ri, Sumida-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Metropolitan Rehabilitation Hospital
Division name Department of rehabilitation medicine
Zip code
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)

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
2009 Year 05 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://journals.sagepub.com/doi/full/10.1177/1545968311408917?url_ver=Z39.88-2003&rfr_id=ori%3Arid%
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
2007 Year 07 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000002404

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.