UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048868 |
|---|---|
| Receipt number | R000055321 |
| Scientific Title | A Standardized Approach for the Rater Training Program in the Action Research Arm Test |
| Date of disclosure of the study information | 2022/09/12 |
| Last modified on | 2023/03/13 14:49:50 |
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Basic information
Public title
Effect of Training on Accuracy and Variance of Action Research Arm Test Scoring
Acronym
Effect of Training on Accuracy of ARAT Scoring
Scientific Title
A Standardized Approach for the Rater Training Program in the Action Research Arm Test
Scientific Title:Acronym
A Standardized Approach for the ARAT Training Program
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) To develop a standardized approach for the rater training program in the action research arm test.
(2) To investigate inter-rater reliability in stroke patients using the developed standardized approach to the action research arm test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the Action Research Arm Test
Key secondary outcomes
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
Kitasato University
Division name
Rehabilitation
Zip code
252-0373
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa, JAPAN
TEL
042-778-8111
s-amano@st.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Yamaoka |
Organization
Shonan-Keiiku Hospital
Division name
Department of rehbabilitation
Zip code
252-0816
Address
4360, Endo, Fujisawa, Kanagawa
TEL
0466-48-0050
Homepage URL
yamaoka.h.ot@gmail.com
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
Shonan-Keiiku Hospital
Address
4360, Endo, Fujisawa, Kanagawa
Tel
0466-48-0050
yamaoka.h.ot@gmail.com
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
| 2022 | Year | 09 | Month | 12 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For the analysis of inter-rater reliability, the total score was assessed using ICCs. The two-way random approach (ICC 2, 1) with absolute agreement was used to compare video observation assessments. The inter-rater reliability of individual item scores was assessed using the weighted kappa coefficient. A Bland-Altman plot was used to assess the magnitude and direction of bias (mean difference and limits of agreements) in measurement agreement between raters.
Sample size was determined using Bonett's methods. A sample size of 28 patients was necessary for a reliability study with two raters, an intraclass correlation planning value of 0.8, a desired precision width of 0.15, and an alpha equal to 0.05.
Management information
Registered date
| 2022 | Year | 09 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055321
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
