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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034474
Receipt No. 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 2018/10/12

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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
Middle name
Last name Michiyuki Kawakami
Organization Tokyo Bay Rehabilitation Hospital
Division name Department of Rehabilitation
Zip code
Address 4-1-1 Yatsu, Narashino-shi, Chiba
TEL 0474539000
Email michiyukikawakami@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Takahashi
Organization Tokyo Bay Rehabilitation Hospital
Division name Department of Rehabilitation
Zip code
Address 4-1-1 Yatsu, Narashino-shi, Chiba
TEL 0474539000
Homepage URL
Email matsuda_y@a6.keio.jp

Sponsor
Institute Tokyo Bay Rehabilitation Hospital
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2018 Year 09 Month 22 Day
Last follow-up date
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
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.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


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