UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036100 |
|---|---|
| Receipt number | R000041126 |
| Scientific Title | Estimating the Minimal Clinically Important Difference of the upper extremity motor function in patients with subacute stroke : A multicenter study. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/09/05 13:51:44 |
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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)
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
OTR.taiki.yoshida@gmail.com
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041126
