UMIN-CTR Clinical Trial

Public title

Reproducibility and Validity of the 15-Item Action Research Arm Test Using a Decision Rule with Clinically-Informed Task Direction

Acronym

Reproducibility and Validity of the 15-Item Action Research Arm Test Using a Decision Rule with Clinically-Informed Task Direction

Scientific Title

Reproducibility and Validity of the 15-Item Action Research Arm Test Using a Decision Rule with Clinically-Informed Task Direction

Scientific Title:Acronym

Reproducibility and Validity of the 15-Item Action Research Arm Test Using a Decision Rule with Clinically-Informed Task Direction

Region

Japan

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the reproducibility and validity of the decision rule in the 15-item ARAT

Basic objectives2

Others

Basic objectives -Others

The item reduction rate (%) before and after applying the decision rule was calculated.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Action Research Arm Test

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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 disorder, or aphasia as an obstacle to daily living; (3) excessive pain; (4) the severe end-stage or uncontrolled medical conditions.

Target sample size

30

Name of lead principal investigator

1st name	Satoru
Middle name
Last name	Amano

Organization

Kitasato University

Division name

School of Allied Health Science

Zip code

252-0373

Address

1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa, JAPAN

TEL

042-778-8111

Email

s-amano@st.kitasato-u.ac.jp

Name of contact person

1st name	Satoru
Middle name
Last name	Amano

Organization

Kitasato University

Division name

School of Allied Health Science

Zip code

252-0373

Address

1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa, JAPAN

TEL

042-778-8111

Homepage URL

Email

s-amano@st.kitasato-u.ac.jp

Institute

Kitasato University

Institute

Department

Personal name

Organization

Kitasato University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kitasato University

Address

1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa, JAPAN

Tel

042-778-8111

Email

s-amano@st.kitasato-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

05

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2021

Year

01

Month

01

Day

Date of IRB

2021

Year

02

Month

09

Day

Anticipated trial start date

2021

Year

02

Month

10

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

To assess the reproducibility of total scores with and without the decision rule for the 15-item ARAT, intraclass correlation coefficients (ICCs) and 95% confidence intervals (CIs) were calculated. ICCs were computed using a two-way mixed-effects model with absolute agreement, to evaluate score consistency under identical conditions.

Agreement between the 15-item ARAT scores with and without the decision rule was assessed using three methods: (1) Bland-Altman analysis, including the mean difference and limits of agreement (LoA); (2) Standard error of measurement (SEM), calculated as the square root of the error variance from a one-way ANOVA model, accounting for systematic differences; and (3) Smallest detectable change (SDC), defined as the minimal change that exceeds measurement error at p < 0.05, computed as SDC = 1.96 * sqrt(2) * SEM. The LoA was defined as the mean difference +/- 1.96 * standard deviation of the differences (SD). To examine item-level agreement, we compared individual item scores between versions with and without the decision rule, and calculated weighted kappa coefficients with 95% CIs. In addition, percent agreement was calculated as the proportion of items with identical scores under both conditions.

To assess criterion-related validity, Spearman's rank correlation coefficients with 95% CIs were computed between the total score of the 15-item ARAT (with the decision rule applied) and both the FMA motor domain score and the total score of the original 19-item ARAT.

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.

Registered date

2025

Year

05

Month

03

Day

Last modified on

2025

Year

05

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065974