UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034474 |
|---|---|
| Receipt number | R000039314 |
| Scientific Title | The relationship between Gait Assessment and Intervention Tool and leg function in patients with stroke |
| Date of disclosure of the study information | 2018/10/13 |
| Last modified on | 2021/11/25 12:20:31 |
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Basic information
Public title
The relationship between Gait Assessment and Intervention Tool and leg function in patients with stroke
Acronym
The relationship between observational gait assessment and leg function in patients with stroke
Scientific Title
The relationship between Gait Assessment and Intervention Tool and leg function in patients with stroke
Scientific Title:Acronym
The relationship between observational gait assessment and leg function in patients with stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the relationship between Gait Assessment and Intervention Tool (G.A.I.T.) and leg function
Basic objectives2
Others
Basic objectives -Others
cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait Assessment and Intervention Tool (G.A.I.T.)
Key secondary outcomes
Fugl-Meyer Assessment (FMA), Stroke Impairment Assessment Set (SIAS), Modified Ashworth scale (MAS), 10m walking test, 6 minutes walking test, Functional Independence Measure (FIM)
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 cerebral infarction or hemorrhage
2.From 30 o 60 days after onset of stroke
3.Able to walk with bare feet under moderate assistance
4.MMSE-J score is 21 or more
Key exclusion criteria
1.Start of antispastic medication during participation to research
2.Complication of serious orthopedic disease which bars gait capability
3.Complication of serious cardiac disease: unstable angina, myocardial infarction shortly after symptom onset, decompensated congestive heart failure, acute cor pulmonale, uncontrolled arrhythmia, serious aortic stenosis, active myocarditis, endocarditis, etc.
4.Complication of serious lower limb joint contracture which bars gait capability
5.Complication of serious liver or renal dysfunction
6.Stop by primary doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
275-0026
Address
4-1-1 Yatsu, Narashino-shi, Chiba
TEL
0474539000
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
275-0026
Address
4-1-1 Yatsu, Narashino-shi, Chiba
TEL
0474539000
Homepage URL
matsuda_y@a6.keio.jp
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Bay Rehabilitation Hospital
Address
4-1-1 Yatsu, Narashino-shi, Chiba
Tel
0474539000
shinsakai@wanreha.net
Secondary IDs
Secondary IDs
YES
Study ID_1
205
Org. issuing International ID_1
Tokyo Bay Rehabilitation Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 13 | 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
| 2018 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 21 | 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 and one month after that, we perform gait assessment and lower limb function evaluation, and examine the relation.
Management information
Registered date
| 2018 | Year | 10 | Month | 12 | Day |
Last modified on
| 2021 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039314
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
