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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032286
Receipt No. R000036816
Scientific Title The effectiveness of SMART rehabilitation for upper extremity paresis after stroke
Date of disclosure of the study information 2018/04/17
Last modified on 2019/04/18

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Basic information
Public title The effectiveness of SMART rehabilitation for upper extremity paresis after stroke
Acronym The effectiveness of SMART rehabilitation for upper extremity paresis after stroke
Scientific Title The effectiveness of SMART rehabilitation for upper extremity paresis after stroke
Scientific Title:Acronym The effectiveness of SMART rehabilitation for upper extremity paresis after stroke
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy and safety of combination therapy with rehabilitation techniques based on severity of upper extremity paresis and brain function after stroke.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Upper extremity function (FMA, ARAT, MAL, MAS, etc)
Key secondary outcomes Surface EMG, Electroencephalogram, functional MRI

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Combination therapy:1) kinesthetic illusion induced by visual stimulation(KiNvis), 2)Brain-machine Interface, 3)Noninvasive brain stimulation, 4)Hybrid assistive neuromuscular stimulation (HANDS)
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) first-ever stroke
2) more than 90 days after stroke onset
3) motor paresis on upper extremity
4) not severe contracture on finger joints
5) ability to walk (with or without any assistance)
Key exclusion criteria 1) severe medical comorbidities unable to perform the therapy
2) severe cognitive or psychiatric disorder
3) pacemaker or implantable cardioverter defibrillators
4) history of epilepsy within 90 days
5) history of specific neurorehabilitation such as rTMS, tDCS, functional electrical stimilation, and repetitive facilitative exercise, and constraint induced movement therapy within 90 days
6) history of botulinum toxin injection or nerve block within 90 days
7) inability to perform electroencephalogram due to skin condition or skull issue
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kazuto
Middle name
Last name Akaboshi
Organization Shonan Keiiku Hospital
Division name Department of Rehabilitation Medicine
Zip code 252-0816
Address 4360 Endo, Fujisawa-city, Kanagawa prefecture
TEL 0466480050
Email redstar@td6.so-net.ne.jp

Public contact
Name of contact person
1st name Keiichiro
Middle name
Last name Shindo
Organization Shonan Keiiku Hospital
Division name Department of Rehabilitation Medicine
Zip code 252-0816
Address 4360 Endo, Fujisawa-city, Kanagawa prefecture
TEL 0466480050
Homepage URL
Email krugreims@yahoo.co.jp

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

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics committee of Shonan Keiiku Hospital
Address 4360 Endo, Fujisawa-city, Kanagawa
Tel 0466480050
Email K-miyazaki@keiiku.gr.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
2018 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 70
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 No longer recruiting
Date of protocol fixation
2017 Year 10 Month 20 Day
Date of IRB
2007 Year 11 Month 02 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2019 Year 03 Month 15 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
2018 Year 04 Month 17 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036816

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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