UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012875 |
|---|---|
| Receipt number | R000015043 |
| Scientific Title | The longitudinal changes in balance function evaluated by the Mini-Balance Evaluation Systems Test (Mini-BESTest) in patients with hemiplegic subacute stroke. |
| Date of disclosure of the study information | 2014/01/16 |
| Last modified on | 2014/01/22 01:08:22 |
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Basic information
Public title
The longitudinal changes in balance function evaluated by the Mini-Balance Evaluation Systems Test (Mini-BESTest) in patients with hemiplegic subacute stroke.
Acronym
The longitudinal changes in balance function in patients with hemiplegic subacute stroke.
Scientific Title
The longitudinal changes in balance function evaluated by the Mini-Balance Evaluation Systems Test (Mini-BESTest) in patients with hemiplegic subacute stroke.
Scientific Title:Acronym
The longitudinal changes in balance function in patients with hemiplegic subacute stroke.
Region
| Japan |
Condition
Condition
Hemiplegic stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate balance function longitudinally and comprehensively in patients with hemiplegic subacute stroke by the Mini-BESTest and to examine relationship between balance function and activities of daily living (ADL), other physical indices and falls.
Basic objectives2
Others
Basic objectives -Others
relevancy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The scores of Mini-BESTest at admission and discharge.
Key secondary outcomes
At admission and discharge
Indices of physical function (Stroke Impairment Assessment Sets, gait speed etc) .
Other well-known balance measures (Berg Balance Scale etc).
Activities of daily living (Functional Independence Measure).
Number of falls during hospitalization.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.First-ever hemiplegic stroke admitted to Tokyo Bay Rehabilitation Hospital.
2.Ability to follow 3-step commands.
3.Ability to understand the instruction of the tasks of Mini-BESTest.
4.Provide written informed consent form.
Key exclusion criteria
1.Impaired consciousness, severe vision problem, severe hearing loss, severe cognitive dysfunction and/or the dementia.
2.Comorbidities that affect the balance function.
3.Musculoskeletal diseases with severe deformity and/or severe pain.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Emiko Tan |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Division of Physical therapy
Zip code
Address
4-1-1 Yatsu,Narashino-shi,Chiba
TEL
047-453-9010
emiko07254@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Emiko Tan |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Division of Physical therapy
Zip code
Address
4-1-1 Yatsu,Narashino-shi,Chiba
TEL
047-453-9010
Homepage URL
emiko07254@gmail.com
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Rehabilitation Medicine, Keio University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京湾岸リハビリテーション病院(千葉県)
Tokyo Bay Rehabilitation Hospital(Chiba)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 16 | 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
| 2013 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The relationship of the Mini-BESTest and other indices of physical function, ADL and falls.
The comparison of validity and responsiveness of the Mini-BESTest and other well-known balance measures (Berg Balance Scale etc).
Management information
Registered date
| 2014 | Year | 01 | Month | 16 | Day |
Last modified on
| 2014 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015043
