UMIN-CTR Clinical Trial

Basic information
Public title	Estimating the Minimal Clinically Important Difference of the upper extremity motor function in patients with subacute stroke : A multicenter study.
Acronym	The MCID of the FMA Upper extremity motor score: a multicenter study.
Scientific Title	Estimating the Minimal Clinically Important Difference of the upper extremity motor function in patients with subacute stroke : A multicenter study.
Scientific Title:Acronym	The MCID of the FMA Upper extremity motor score: a multicenter study.
Region	Japan

Condition
Condition	Hemiparetic stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to estimate the MCID of FMA upper extremity motor score in patients with subacute stroke.
Basic objectives2	Others
Basic objectives -Others	Estimate the MCID of FMA
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fugl-Meyer Assessment upper extremity motor score (FMA-UE) Patient-reported outcomes (PROs) Observer-reported outcomes (OROs)
Key secondary outcomes	Stroke Impairment Assessment Set (SIAS) Action Research Arm Test (ARAT) Motor Activity Log (MAL) Range of Motion (ROM) of the upper extremity Modified Ashworth Scale (MAS) of the upper extremity Functional Independence Measure (FIM) Brunnstrom stage of upper extremity and hand function National Institute of Health Stroke Scale (NIHSS)

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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.First stroke patients with a cerebral hemisphere lesion 2.the patients with upper extremity hemiparesis. (FMA-UE < 66) 3.Two weeks to eight weeks had passed since stroke. 4.Mini-Mental State Examination > 23
Key exclusion criteria	1.Severe cognitive dysfunction. 2.Severe psychological dysfunction. 3.Post stroke depression. 4.server pain on affected limb. 5.Cerebellar lesion.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Michiyuki Middle name Last name Kawakami
Organization	1.Keio University School of Medicine. 2.Tokyo Bay Rehabilitation Hospital
Division name	1.Department of Rehabilitation Medicine 2.Department of Rehabilitation
Zip code	1.160-0016 2.275-0026
Address	1. 35 Shinanomachi, Shinjuku, Tokyo 2. 4-1-1 Yatsu, Narashino-shi, Chiba
TEL	1.03-3353-1211(2.047-453-9000)
Email	michiyukikawakami0212@yahoo.co.jp

Public contact
Name of contact person	1st name Taiki Middle name Last name Yoshida
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Department of Rehabilitation
Zip code	275-0026
Address	4-1-1 Yatsu, Narashino-shi, Chiba
TEL	047-453-9010
Homepage URL
Email	OTR.taiki.yoshida@gmail.com

Sponsor
Institute	Tokyo Bay Rehabilitation Hospital
Institute
Department

Funding Source
Organization	Tokyo Bay Rehabilitation Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	1.Department of Rehabilitation Medicine, Keio University School of Medicine. 2.Saiseikai Higashikanagawa Rehabilitation Hospital 3.Brain Attack Center Ota Memorial Hospital. 4.Asahikawa Rehabilitation Hospital. 5.Higashisaitama National Hospital.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics committee of Tokyo Bay Rehabilitation Hospital
Address	4-1-1 Yatsu, Narashino-shi, Chiba
Tel	047-453-9000
Email	shinsakai@wanreha.net

Secondary IDs
Secondary IDs	YES
Study ID_1	20170264
Org. issuing International ID_1	Keio University School of Medicine at ethical sommittee.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京湾岸リハビリテーション病院（千葉県）　Tokyo Bay Rehabilitation Hospital,Chiba 済生会東神奈川リハビリテーション病院（神奈川県）　Saiseikai Higashikanagawa Rehabilitation Hospital, Kanagawa 脳神経センター大田記念病院（広島県）　Brain Attack Center Ota Memorial Hospital, Hiroshima 旭川リハビリテーション病院（北海道）　Asahikawa Rehabilitation Hospital, Hokkaido 東埼玉病院（埼玉県）　Higashisaitama National Hospital, Saitama

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 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
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	Enrolling by invitation
Date of protocol fixation	2019 Year 01 Month 25 Day
Date of IRB	2019 Year 01 Month 25 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	At the time of hospital admission, we assess the upper extremity motor function with following scale; FMA-UE, SIAS, ARAT, MAL, ROM, MAS, FIM, Br.stage, NIHSS. At the time of 4 weeks and 8 weeks after the initial assessments , we assess the motor function again with scales described above and PROs, OROs.From the acquired data, we examine the MCID.

Management information
Registered date	2019 Year 03 Month 06 Day
Last modified on	2019 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041126