UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047165 |
|---|---|
| Receipt number | R000053744 |
| Scientific Title | Minimal Clinically Important Difference of Upper Extremity Outcome Measures in Stroke: A Systematic Review. |
| Date of disclosure of the study information | 2022/03/14 |
| Last modified on | 2023/09/14 10:09:57 |
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Basic information
Public title
Minimal Clinically Important Difference of Upper Extremity Outcome Measures in Stroke: A Systematic Review.
Acronym
Minimal Clinically Important Difference of Upper Extremity Outcome Measures in Stroke: A Systematic Review.
Scientific Title
Minimal Clinically Important Difference of Upper Extremity Outcome Measures in Stroke: A Systematic Review.
Scientific Title:Acronym
Minimal Clinically Important Difference of Upper Extremity Outcome Measures in Stroke: A Systematic Review.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate and summarize the minimal clinically important difference in the assessment of upper extremity function in stroke patients.
Basic objectives2
Others
Basic objectives -Others
Reliability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer assessment(FMA)
Action Research Arm Test(ARAT)
Motor Activity Log(MAL)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Original papers of studies that fulfill criteria (1) and (2)
Criteria (1) Studies with the following upper limb function assessment outcomes in stroke patients
Fugl-Meyer assessment (FMA)
Action Research Arm Test (ARAT)
Motor Activity Log (MAL)
Criteria (2)
Studies for which the Minimum Clinically Important Difference (MCID) is calculated
Studies in which Minimal Detectable Change (MDC) is calculated
Key exclusion criteria
Interventions other than rehabilitation therapy
In the case where the calculation method of MCID and MDC is not described
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | YUINE |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-840-2220
yuinehi@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | YUINE |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-840-2220
Homepage URL
yuinehi@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 14 | 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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 09 | Month | 13 | Day |
Other
Other related information
We will search MEDLINE, CINAHL, OT seeker, and the Physiotherapy Evidence Database (PEDro). There are no restrictions based on language or publication status. Two reviewers will independently select the studies to be included in the systematic review using the inclusion criteria. Researchers are not informed of each other's decisions and disagreements are moderated by third authors. The third review author evaluates the relevant studies and makes a decision by discussion. Record decisions using Excel-based forms. The following research characteristics are extracted from selected studies.
Method; MCID, MDC calculation method, area under curve (AUC), reliability, measurement error.
Participants; Number of subjects, mean age, age range, sex, type of stroke, period from onset, inclusion criteria, exclusion criteria.
intervention; Intervention content, duration, and frequency.
Hybrid9-item instruments are used to assess risk of bias.A meta-analysis will be performed only if the interventions and participants are sufficiently similar. The minimum number of studies for data synthesis will be two.
Management information
Registered date
| 2022 | Year | 03 | Month | 14 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053744
