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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000024425
Receipt No. R000028109
Scientific Title Graduation Constraint Induced Movement therapy for Chronic Stroke patient with severe upper extremity paresis
Date of disclosure of the study information 2017/03/31
Last modified on 2019/05/24

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Basic information
Public title Graduation Constraint Induced Movement therapy for Chronic Stroke patient with severe upper extremity paresis
Acronym Graduation Constraint Induced Movement therapy for Chronic Stroke patient
Scientific Title Graduation Constraint Induced Movement therapy for Chronic Stroke patient with severe upper extremity paresis
Scientific Title:Acronym Graduation Constraint Induced Movement therapy for Chronic Stroke patient
Region
Japan

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

Objectives
Narrative objectives1 To expand the indication of Constraint Induced Movement Therapy(CI-tx) for patients with more severe upper extremity paresis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fugl-Meyer upper motor score, SIAS motor score, WMFT pre- and post- intervention, 3M after the intervention
Key secondary outcomes MAL14, Spasticity, Sensory function, Electrophysiologycal assessments(reciprocal inhibition)

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 To interfere the movement of non-paretic limb
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
125 years-old >=
Gender Male and Female
Key inclusion criteria -Chronic Stroke patients with hemiplegia
-more than 6month from the onset
-Mild cognitive dysfunction and/or aphasia is permitted with MMSE > 20/30 and to be able to understand the objective of this experiment and to cooperate with the intervention.
-Independent in Ambulatory and basic ADL
-SIAS proximal U/E >= 3, distal U/E >=1b
-No contracture or severe pain
Key exclusion criteria contraindication for physical therapies
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Meigen Liu
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinano-machi Shinjuku-ku
TEL 03-5363-3833
Email meigenliukeio@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Syoichi Tashiro
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35
TEL +81905363-3833
Homepage URL
Email s-tashiro@umin.net

Sponsor
Institute 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
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
2017 Year 03 Month 31 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 Suspended
Date of protocol fixation
2016 Year 10 Month 15 Day
Date of IRB
2017 Year 02 Month 01 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2020 Year 05 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 16 Day
Last modified on
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028109

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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