UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050559 |
|---|---|
| Receipt number | R000057584 |
| Scientific Title | Changes in gait performance during hospitalization for stroke (Multicenter study) |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/04/13 16:37:47 |
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Basic information
Public title
Changes in gait performance during hospitalization for stroke (Multicenter study)
Acronym
Changes in gait performance during hospitalization for stroke
Scientific Title
Changes in gait performance during hospitalization for stroke (Multicenter study)
Scientific Title:Acronym
Changes in gait performance during hospitalization for stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationships between changes in gait and physical performance during hospitalization through longitudinal observation
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait speed
Key secondary outcomes
Joint motion and acceleration during gait
Fugl-Meyer Assessment of the lower Extremity
Berg Blance Scale
The Activities-specific Balance Confidence
Physical activity
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) First onset of post-stroke hemiparesis
2) Stable medical condition
3) Mini-mental state examination score >19 points
Key exclusion criteria
1) Severe cardiopulmonary disease
2) Severe sensory disturbance, ataxia, or higher brain dysfunction.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | sota |
| Middle name | |
| Last name | araki |
Organization
Tohoku Fukushi University
Division name
Faculty of Health sciences Department of Rehabilitation
Zip code
989-3201
Address
6-149-1, Kunimigaoka, Aoba-Ky, Sendai
TEL
022-728-6000
s-araki@tfu.ac.jp
Public contact
Name of contact person
| 1st name | Sota |
| Middle name | |
| Last name | Araki |
Organization
Tohoku Fukushi University
Division name
Faculty of Health sciences Department of Rehabilitation
Zip code
989-3201
Address
6-149-1, Kunimigaoka, Aoba-Ky, Sendai
TEL
022-728-6000
Homepage URL
s-arakii@tfu.ac.jp
Sponsor or person
Institute
Tohoku Fukushi University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku Fukushi University
Address
6-149-1, Kunimigaoka, Aoba-Ky, Sendai
Tel
022-728-6000
s-araki@tfu.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
Other administrative information
Date of disclosure of the study information
| 2023 | 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
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The gait of stroke patients is measured using magnetic inertial measurement units.
Management information
Registered date
| 2023 | Year | 03 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057584
| 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 |
