UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022188
Receipt No. R000025563
Scientific Title Clinimetric Properties of the Fugl-Meyer Assessment with Adapted Guidelines for the Assessment of Arm Function in Hemiparetic Patients after Stroke
Date of disclosure of the study information 2016/05/03
Last modified on 2020/02/19

* 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 Clinimetric Properties of the Fugl-Meyer Assessment with Adapted Guidelines for the Assessment of Arm Function in Hemiparetic Patients after Stroke
Acronym Clinimetric Properties of the Fugl-Meyer Assessment
Scientific Title Clinimetric Properties of the Fugl-Meyer Assessment with Adapted Guidelines for the Assessment of Arm Function in Hemiparetic Patients after Stroke
Scientific Title:Acronym Clinimetric Properties of the Fugl-Meyer Assessment
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 clinimetric properties (reliability, validity, and responsiveness) with adapted (Japanese) guidelines for the Fugl-Meyer Assessment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Scores of the Fugl-Meyer Assessment. Scores for each ordinally scaled item range from 0 to 2, scores for the test range from 0 to 66.
Key secondary outcomes The Action Research Arm Test, the Box and Block Test, and 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 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 Kazuhisa
Middle name
Last name Domen
Organization Hyogo College of Medicine
Division name Department of Rehabilitation Medicine
Zip code 663-8501
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 Satoru
Middle name
Last name Amano
Organization Hospital of Hyogo College of Medicine
Division name Department of physical medicine and rehabilitation
Zip code 663-8501
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 Japan

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 663-8501, Japan
Tel 0798-45-6066
Email rinri@hyo-med.ac.jp

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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 30
Results
Regarding the non-simultaneous and simultaneous inter-rater reliability, ICC ranged from 0.809-0.983 (P<0.001) and 0.991-0.999 (P<0.001), respectively. Regarding the simultaneous intra-rater reliability, ICC ranged from 0.994-0.999 (P<0.001).
Results date posted
2020 Year 02 Month 19 Day
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
2016 Year 04 Month 18 Day
Anticipated trial start date
2016 Year 05 Month 03 Day
Last follow-up date
2019 Year 05 Month 03 Day
Date of closure to data entry
2019 Year 05 Month 23 Day
Date trial data considered complete
2019 Year 08 Month 07 Day
Date analysis concluded
2019 Year 10 Month 02 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 (ARAT), Fugl-Meyer Assessment for upper extremity (FMA-UE) and Box and Block Test (BBT), Motor Activity Log (MAL) 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.

For reliability and validity, 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
2020 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025563

Research Plan
Registered date File name
2016/05/03 実施計画書(No. 2225).docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.