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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042514
Receipt No. R000048530
Scientific Title Clinimetric Properties of the Action Research Arm Test Using Guttman Scales for Substes in Hemiparetic Patients After Stroke
Date of disclosure of the study information 2020/11/21
Last modified on 2020/11/20

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Basic information
Public title Is It Appropriate To Use Guttman Scales for the Action Research Arm Test in Hemiparetic Patients After Stroke
Acronym Clinimetric Properties of the ARAT Using Guttman Scales
Scientific Title Clinimetric Properties of the Action Research Arm Test Using Guttman Scales for Substes in Hemiparetic Patients After Stroke
Scientific Title:Acronym Clinimetric Properties of the ARAT Using Guttman Scales
Region
Japan

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

Objectives
Narrative objectives1 The aim of the present study is to answer the following research question:

Can the the scoring rules related to Guttman scale described by Lyle be supported by the obtained data? This was investigated in three ways:
Basic objectives2 Others
Basic objectives -Others 1) Comparison between the ARAT with or without Guttman scales
2) Reliability of the ARAT with Guttman Scales
3) Validity of the ARAT with Guttman Scales
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Scores of the ARAT with Guttman Scales.
Key secondary outcomes Scores of the ARAT without Guttman Scales, the Fugl-Meyer Assessment, the Box and Block Test, the Motor Activity Log.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients with (incomplete) upper extremity paresis resulting from stroke are included.
Key exclusion criteria Exclusion criteria include the following: (1) clear sign of dementia; (2) mental di sorder, or aphasia as an obstacle to dail y living; (3) excessive pain; (4) the sever e end-stage or uncontrolled medical co nditions.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Satoru
Middle name
Last name Amano
Organization Hyogo College of Medicine
Division name Department of Rehabilitation Medicine
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6388
Email satorufornaimu@yahoo.co.jp

Public contact
Name of contact person
1st name Satoru
Middle name
Last name Amano
Organization Hyogo College of Medicine
Division name Department of Rehabilitation Medicine
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6388
Homepage URL
Email satorufornaimu@yahoo.co.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hyogo College of Medicine
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 66 3-8501, Japan
Tel 0798-45-6066
Email rinri@hyo-med.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 18503-200904
Org. issuing International ID_1 Niigata University of Health and Welfare
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 21 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 01 Day
Date of IRB
2020 Year 09 Month 04 Day
Anticipated trial start date
2020 Year 12 Month 03 Day
Last follow-up date
2020 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2021 Year 01 Month 31 Day

Other
Other related information A retrospective single-center study involving 30 patients was conducted. The data used in this study come from the video evaluation obtained during the study conducted between 2016 and 2017 at the college hospital. The study was registered with the University Hospital Medical Information Network Clinical Trial Registry (UMIN000022173) in May 2016 as a ore-initiation condition.

The inter-rater reliability/agreement, the validity of the shortened ARAT with Guttman scales will be assessed. The protocol for this study was approved by the Hyogo College of Medicine Institutional Review Board and was conducted in a manner that conformed to the approved protocol.

Management information
Registered date
2020 Year 11 Month 20 Day
Last modified on
2020 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048530

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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