UMIN-CTR Clinical Trial

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 Meigen Middle name Last name Liu
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Zip code	160-8582
Address	35 Shinano-machi Shinjuku-ku
TEL	03-5363-3833
Email	meigenliukeio@mac.com

Public contact
Name of contact person	1st name Syoichi Middle name Last name Tashiro
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Zip code	160-8582
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	Keio University School of Medicine
Address	Shinano-machi 35, Shinjuku city, Tokyo
Tel	03-5363-3503
Email	med-rinri-jimu@adst.keio.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	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 10 Month 19 Day

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