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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022509
Receipt No. R000025480
Scientific Title The efficacy of upper extremity robotic therapy combined with constraint-induced movement therapy in chronic post-stroke hemiplegia.
Date of disclosure of the study information 2016/07/01
Last modified on 2019/12/02

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Basic information
Public title The efficacy of upper extremity robotic therapy combined with constraint-induced movement therapy in chronic post-stroke hemiplegia.
Acronym ReoGo-J study
Scientific Title The efficacy of upper extremity robotic therapy combined with constraint-induced movement therapy in chronic post-stroke hemiplegia.
Scientific Title:Acronym ReoGo-J study
Region
Japan

Condition
Condition Post-stroke upper extremity hemiplegia
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of robotic therapy alone or conbined with constraint-induced movement therapy on motor function and ADL in chronic post-stroke hemiplegiain patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Change in upper extremity Fugl-Meier acore
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Self training with robotic device + Usual care
Interventions/Control_2 Self training with robotic device + Constraint-induced movement therapy
Interventions/Control_3 Usual care
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 and Female
Key inclusion criteria 1. Patients must be able to understand and willing to sign a written informed consent
2. Age >= 20 and <80
3. Patients who experienced clinically incipient stroke upon the cerebellar tentorium more than 6 months ago
Key exclusion criteria 1. Patients with clinically multiple stroke or stroke below the cerebellar tentorium
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Kazuhisa
Middle name
Last name Domen
Organization Hyogo College of Medicine
Division name Department of Rehabilitation Medicine
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
TEL 0798-45-6111
Email domen@neuro-reha.org

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Uchiyama
Organization Hyogo College of Medicine
Division name Department of Rehabilitation Medicine
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL 0798-45-6111
Homepage URL
Email domen@neuro-reha.org

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Teijin Pharma Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hyogo College of Medicine Independent Ethics Committee
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
Tel 0798-45-6066
Email rinri@hyo-med.ac.jp

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 07 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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 07 Day
Date of IRB
2016 Year 04 Month 18 Day
Anticipated trial start date
2016 Year 11 Month 29 Day
Last follow-up date
2019 Year 02 Month 08 Day
Date of closure to data entry
2019 Year 03 Month 15 Day
Date trial data considered complete
2019 Year 03 Month 15 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 05 Month 28 Day
Last modified on
2019 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025480

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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