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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022192
Receipt No. R000025566
Scientific Title Interrater Reliability of Remote Evaluation for the Fugl-Meyer Assessment and the Action Research Arm Test in Hemiparetic Patients after Stroke
Date of disclosure of the study information 2016/05/03
Last modified on 2018/09/16

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Basic information
Public title Interrater Reliability of Remote Evaluation for the Fugl-Meyer Assessment and the Action Research Arm Test in Hemiparetic Patients after Stroke
Acronym Reliability of Remote Evaluation for the Arm Function and Activity
Scientific Title Interrater Reliability of Remote Evaluation for the Fugl-Meyer Assessment and the Action Research Arm Test in Hemiparetic Patients after Stroke
Scientific Title:Acronym Reliability of Remote Evaluation for the Arm Function and Activity
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 assess its test-retest reliability (Remote evaluation: direct observation versus videotaping) for the Fugl-Meyer Assessment and Action Research Arm Test.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Fugl-Meyer Assessment
Key secondary outcomes Action Research Arm Test

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 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

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Domen
Organization Hyogo College of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
TEL 0798-45-6644
Email office@craseed.org

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Amano
Organization Hospital of Hyogo College of Medicine
Division name Department of physical medicine and rehabilitation
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
TEL 0798-45-6388
Homepage URL
Email satoru@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization TEIJIN PHARMA LIMITED
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 兵庫医科大学病院(兵庫県); Hospital of Hyogo College of Medicine

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1080/10749357.2018.1481569
Number of participants that the trial has enrolled
Results
A prospective, cross-sectional, single-center study involving 30 patients with mild-to-severe hemiparesis was conducted.

Regarding the sum scores of the total/subtests of the FMA and ARAT, the intraclass correlation coefficient ranged from 0.992 to 0.998 (95% confidence interval [CI], 0.960 to 0.999; P<0.0001) and Spearman's rho ranged from 0.949 to 1.000 (95% CI, 0.985 to 1.000; P<0.0001). Regarding the individual item scores of the outcome measures, weighted kappa (median of the sum scores of total/subtests) ranged from 0.921 to 1.000.
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 Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 03 Day
Last follow-up date
2018 Year 08 Month 03 Day
Date of closure to data entry
2018 Year 08 Month 03 Day
Date trial data considered complete
2018 Year 08 Month 03 Day
Date analysis concluded
2018 Year 08 Month 03 Day

Other
Other related information Design: case-control study

Data collection/analysis will start in April 2016 and end in April 2020.

The present study includes a sample of convenience of patients hospitalized at the departments of rehabilitation in a university hospital in Japan speaking Japanese. Patients fulfilling inclusion criteria who agreed to participate will be included. The Action Research Arm Test and Fugl-Meyer Assessment for upper extremity are employed.

The measurements are directly performed by the trained evaluators. Each task will be described and modeled by the trained therapists, and the patients are not allowed to practice the task.

Two measurements will be performed with a 2-day interval for the patients with acute and sub-acute stroke (<180 days from onset). For the patients with chronic stroke (>=;180 days from onset), two measurements will be performed with a 7-day interval.

Management information
Registered date
2016 Year 05 Month 02 Day
Last modified on
2018 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025566

Research Plan
Registered date File name
2016/05/03 03. 倫理審査計画書(リモート)verSA.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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