UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a vestibular-focused approach on balance performance in older adults: a systematic review
Acronym	Effects of a vestibular-focused approach on balance performance in older adults: a systematic review
Scientific Title	Effects of a vestibular-focused approach on balance performance in older adults: a systematic review
Scientific Title:Acronym	Effects of a vestibular-focused approach on balance performance in older adults: a systematic review
Region	Japan

Condition
Condition	older adults
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this systematic review is to consolidate the evidence on the usefulness of a vestibular-focused approach to balance performance in older adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Balance testing
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	P(participants): older adults I(intervention): vestibular-focused approach C(control): N/A O(outcome): balance testing
Key exclusion criteria	Research articles which does not meet PICO
Target sample size

Research contact person
Name of lead principal investigator	1st name Tsubasa Middle name Last name Mitsutake
Organization	Fukuoka International University of Health and Welfare
Division name	Department of Physical Therapy, Faculty of Medical Science
Zip code	814-0001
Address	3-6-40 Momochihama, Sawaraku, Fukuoka, Japan
TEL	092-832-1200
Email	t-mitsutake@takagigakuen.ac.jp

Public contact
Name of contact person	1st name Tsubasa Middle name Last name Mitsutake
Organization	Fukuoka International University of Health and Welfare
Division name	Department of Physical Therapy, Faculty of Medical Science
Zip code	814-0001
Address	3-6-40 Momochihama, Sawaraku, Fukuoka, Japan
TEL	092-832-1200
Homepage URL
Email	t-mitsutake@takagigakuen.ac.jp

Sponsor
Institute	Fukuoka International University of Health and Welfare
Institute
Department

Funding Source
Organization	JSPS KAKENHI
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	Fukuoka International University of Health and Welfare ethics review committee
Address	3-6-40 Momochihama, Sawaraku, Fukuoka, Japan
Tel	092-832-1200
Email	fiuhw-rinri@takagigakuen.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	2022 Year 02 Month 21 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	Preinitiation
Date of protocol fixation	2022 Year 02 Month 18 Day
Date of IRB	2022 Year 02 Month 18 Day
Anticipated trial start date	2022 Year 02 Month 18 Day
Last follow-up date	2023 Year 02 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Search strategy and study selection The Medline, CENTRAL, PEDro, and CINAHL electronic databases were comprehensively searched. After excluding duplicates, two reviewers will independently screen each article based on the title and abstract using predetermined eligibility criteria in order to determine relevant manuscripts for full text review. Subsequently, full text copies of articles that are not excluded based on the title or abstract were retrieved, and the inclusion and exclusion criteria will be reapplied to these studies to determine suitability for final inclusion. Any disagreements during the article screening and selection will be resolved through discussion, and decisions will be made by a third person if the two reviewers will not reach a consensus. Data extraction Predesigned spreadsheets that were created using Microsoft Excel 365 will be used to extract data on participants, intervention, outcome measurements, and results. Two reviewers will discuss and decide on the extraction data, and a third person will confirm. Risk of bias evaluation in individual studies To evaluate the risk of bias in each study, two researchers will independently apply the tool to assess risk of bias in PEDro scale.

Management information
Registered date	2022 Year 02 Month 18 Day
Last modified on	2022 Year 08 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053561