UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048479 |
|---|---|
| Receipt number | R000055247 |
| Scientific Title | Relationship between the estimation error and physical function in patients with stroke |
| Date of disclosure of the study information | 2022/07/27 |
| Last modified on | 2023/01/31 14:51:44 |
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Basic information
Public title
Relationship between the estimation error and physical function in patients with stroke
Acronym
The estimation error of stroke patient
Scientific Title
Relationship between the estimation error and physical function in patients with stroke
Scientific Title:Acronym
The estimation error of stroke patient
Region
| Japan |
Condition
Condition
Patient with stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study investigated whether estimation error is related to physical function in patients with stroke.
Basic objectives2
Others
Basic objectives -Others
This study aimed to investigate whether there are differences in walking and balance ability according to executive function in patients with stroke.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimation error (Imegined timed up and go test - Timed up and go test)
Key secondary outcomes
Berg Balance Scale
Brunnstrom Recovery Stage
Trail Making Test
Mini Mental State Examination
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
| 18 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ability to walk without assistance using aids
absence of lower limb orthopedic disease
Key exclusion criteria
diagnosis of dementia
diagnosis of severehigher brain dysfunction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Sakai |
Organization
Chiba Prefectural University of Health Sciences
Division name
Faculty of Healthcare Sciences
Zip code
260-0801
Address
645-1, Nitona-cho, Chuo-ku, Chiba city, Chiba, Japan 260-0801
TEL
043-305-2164
katsuya.sakai_56@cpuhs.ac.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Sakai |
Organization
Chiba Prefectural University of Health Sciences
Division name
Faculty of Healthcare Sciences
Zip code
260-0801
Address
645-1, Nitona-cho, Chuo-ku, Chiba city, Chiba, Japan 260-0801
TEL
043-305-2164
Homepage URL
katsuya.sakai_56@cpuhs.ac.jp
Sponsor or person
Institute
Chiba Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
No
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
Chiba Prefectural University of Health Sciences
Address
645-1, Nitona-cho, Chuo-ku, Chiba city, Chiba, Japan 260-0801
Tel
043-305-2164
katsuya.sakai_56@cpuhs.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20210907
Org. issuing International ID_1
Ukai Rehabilitation Hospital
Study ID_2
00001
Org. issuing International ID_2
Reiwa Rehabilitation Hospital
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 27 | 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
78
Results
This study included 71 individuals diagnosed with a stroke. The OE group had a significantly higher estimation error than the AE group. Moreover, the OE group had significantly lower TUGT and BBS than the AE group.
Results date posted
| 2023 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Adverse events was nothing.
Outcome measures
Timed Up and Go Test
Imagined Timed Up and Go Test
Visual Analogue Scale
10m walking speed
Berg Balance Scale
Functional Independence Measure
Mini-Mental State Examination
Brunnstrom Recovery Stage
Stroke Impairment Assessment Set
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2022 | Year | 07 | Month | 27 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055247
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
