UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042514 |
|---|---|
| Receipt number | 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 | 2023/05/25 13:25:37 |
* 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
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
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
satorufornaimu@yahoo.co.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Submitting
Publication of results
Unpublished
Result
URL related to results and publications
Submitting
Number of participants that the trial has enrolled
30
Results
Satoru Amano, Atsushi Umeji, Kayoko Takahashi, Takashi Takebayashi, Yuki Uchiyama & Kazuhisa Domen (2022): Psychometric properties of the Action Research Arm Test using decision rules for skipping items in hemiparetic patients after stroke: a retrospective study, Disability and Rehabilitation, DOI: 10.1080/09638288.2022.2153177
Results date posted
| 2022 | Year | 11 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Stroke
Participant flow
Submitting
Adverse events
None
Outcome measures
Action research arm test
Fugl-myer assessment
Motor activity log
Box and block test
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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.
Satoru Amano, Atsushi Umeji, Kayoko Takahashi, Takashi Takebayashi, Yuki Uchiyama & Kazuhisa Domen (2022): Psychometric properties of the Action Research Arm Test using decision rules for skipping items in hemiparetic patients after stroke: a retrospective study, Disability and Rehabilitation, DOI: 10.1080/09638288.2022.2153177
Management information
Registered date
| 2020 | Year | 11 | Month | 20 | Day |
Last modified on
| 2023 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048530
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/11/23 | 研究計画書_UMIN.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
