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Recruitment status Completed
Unique ID issued by UMIN UMIN000011762
Receipt No. R000013755
Scientific Title Validation of Japanese version of BESTest and Mini-BESTest for balance assessments
Date of disclosure of the study information 2013/09/14
Last modified on 2014/04/13

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Basic information
Public title Validation of Japanese version of BESTest and Mini-BESTest for balance assessments
Acronym Validation of Japanese version of BESTest and Mini-BESTest for balance assessments
Scientific Title Validation of Japanese version of BESTest and Mini-BESTest for balance assessments
Scientific Title:Acronym Validation of Japanese version of BESTest and Mini-BESTest for balance assessments
Region
Japan

Condition
Condition Patients with balance disorders and healthy adults
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To translate BESTest and Mini-BESTest, newly developed balance function assessment sets, into Japanese and evaluate those validity
Basic objectives2 Others
Basic objectives -Others Validation study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between Japanese version of BESTest or Mini-BESTest and other well-known balance measures (Berg Balance Scale, Activities-specific balance confidence scale and Falls Efficacy Scale International)
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria <Patients>
With a neurological or musculoskeletal condition ( cerebrovascular diseases, neuromuscular diseases, hip fracture, osteoporosis)
Able to ambulate 6m without human assistance
Able to follow 3-step commands
Able to understand commands in BESTest or Mini-BESTest
Consent to participate in this study

<Healthy adults>
No past history of neurological and/or musculoskeletal diseases
Consent to participate in this study
Key exclusion criteria With excessive fatigue or pain during the balance tasks
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eri Otaka
Organization Eisei Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 583-15 Kunugida-chou, Hachiouji, Tokyo, Japan
TEL 0426-61-4108
Email eyokohama93@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Eri Otaka
Organization Eisei Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 583-15 Kunugida-chou, Hachiouji, Tokyo, Japan
TEL 0426-61-4108
Homepage URL
Email eyokohama93@gmail.com

Sponsor
Institute Eisei Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Rehabilitation Medicine, Keio University School of Medicine
Keiyu Orthopaedic Hospital
NHO Higashisaitama Hospital
Tokyo Bay Rehabilitation Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 永生病院(東京都)、慶友整形外科病院(群馬県)、国立病院機構東埼玉病院(埼玉県)、東京湾岸リハビリテーション病院(千葉県)

Eisei Hospital
Keiyu Orthopedic Hospital
NHO Higashisaitama Hospital
Tokyo Bay Rehabilitation Hospital

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 14 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 Completed
Date of protocol fixation
2013 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 14 Day
Last follow-up date
Date of closure to data entry
2013 Year 12 Month 26 Day
Date trial data considered complete
Date analysis concluded
2014 Year 03 Month 15 Day

Other
Other related information To explore whether there are good correlation between BESTest or Mini-BESTest and other well-known balance measures (Berg Balance Scale, Activities-specific balance confidence scale and Falls Efficacy Scale International).

Management information
Registered date
2013 Year 09 Month 13 Day
Last modified on
2014 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013755


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