UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035433
Receipt No. R000040362
Official scientific title of the study Predictors of long-term effects using tensor images in Constraint-induced movement therapy (CIMT)
Date of disclosure of the study information 2019/01/07
Last modified on 2019/01/03

* 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
Official scientific title of the study Predictors of long-term effects using tensor images in Constraint-induced movement therapy (CIMT)
Title of the study (Brief title) Predictors of long-term effects In CIMT(A tensor imaging study)
Region
Japan

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

Objectives
Narrative objectives1 Analyze predictors of long-term effectives in CIMT using by tensor imaging
Basic objectives2 Others
Basic objectives -Others Mechanism of the effect by CIMT
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes delta-FMA
Key secondary outcomes delta-ARAT, delta-WMFT, delta-MAL

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 CIMT
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We enrolled patients with chronic stroke (>7 months from stroke onset) who received CIMT as outpatients at the Hyogo College of Medicine Hospital
Key exclusion criteria Exclusion criteria were as follows: severe balance or walking disorders as indicated by the need for assistance in any ADL; substantial use of the affected upper extremity before CIMT, as indicated by a score >2.5 points on the Amount of Use (AOU) scale of the Motor Activity Log (MAL); dementia or cognitive disorders, as indicated by a Mini-Mental State Examination score <24 points; severe aphasia or apraxia inhibiting CIMT performance; the presence of another uncontrolled medical condition or severe end-stage disease; severe contraction around upper extremity joints; the absence of pre-CIMT magnetic resonance imaging
(MRI) data; missing clinical assessment data from any follow-up time point; and receiving any other rehabilitation intervention for the affected upper extremity after CIMT.
Target sample size 20

Research contact person
Name of lead principal investigator Kazuhisa Domen
Organization Hyogo College of Medicine
Division name Department of Rehabilitation Medicine
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
TEL +81-(798)45-6881
Email k.maru5081@gmail.com

Public contact
Name of contact person Kohei Marumoto
Organization Hyogo Prefectural Rehabilitation Hospital at Nishi-Harima
Division name Department of Physical Medicine and Rehabilitation
Address 1-7-1, Kouto, Shingu-cho, Tatsuno, Hyogo, Japan679-5165
TEL +81-(791)58-1050
Homepage URL
Email k.maru5081@gmail.com

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
2019 Year 01 Month 07 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2010 Year 04 Month 01 Day
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 01 Month 03 Day
Last modified on
2019 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040362

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.