UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062742 |
|---|---|
| Receipt number | R000070033 |
| Scientific Title | A scoping review of studies evaluating the measurement properties of the modified Clinical Test of Sensory Interaction and Balance |
| Date of disclosure of the study information | 2026/09/19 |
| Last modified on | 2026/08/31 09:58:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A scoping review summarizing studies on the reliability and validity of the mCTSIB balance assessment
Acronym
mCTSIB reliability and validity review
Scientific Title
A scoping review of studies evaluating the measurement properties of the modified Clinical Test of Sensory Interaction and Balance
Scientific Title:Acronym
mCTSIB Measurement Properties ScR
Region
| Japan |
Condition
Condition
Balance impairment, postural control impairment, and conditions relevant to their assessment
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this scoping review is to systematically map and characterize primary studies evaluating the measurement properties of the modified Clinical Test of Sensory Interaction and Balance (mCTSIB). Specifically, this review will include studies addressing reliability, validity, measurement error, responsiveness, as well as discrimination, prediction, and methodological or protocol-related variations. Furthermore, the review will distinguish between studies in which the mCTSIB itself is the primary focus (Core) and those in which it is used as a reference or comparator (Context), in order to clarify their respective roles within the evidence base.
Basic objectives2
Others
Basic objectives -Others
Systematic mapping of evidence on the measurement properties of the mCTSIB
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The distribution and characteristics of studies evaluating the measurement properties of the mCTSIB. Specifically, reported evidence on reliability (test-retest, inter-rater, intra-rater), validity (construct, criterion, convergent), measurement error (SEM, SDC, MDC, limits of agreement), responsiveness, and discrimination/prediction (ROC, AUC, sensitivity, specificity, cut-off values) will be extracted and summarized.
Key secondary outcomes
Target populations (e.g., disease groups, age groups), implementation type of the mCTSIB (time-based or instrumented), comparator measures, analytical methods, and classification of each study as Core or Context. In addition, methodological variations, such as protocol conditions, foam conditions, and scoring approaches, will be summarized.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Original studies involving the modified Clinical Test of Sensory Interaction and Balance (mCTSIB) or instrumented mCTSIB will be included if they evaluate at least one of the following as a primary aim or primary analysis: reliability (e.g., test-retest, inter-rater), validity (e.g., construct, criterion), measurement error (e.g., SEM, SDC, limits of agreement), responsiveness, discrimination or prediction (e.g., ROC, AUC, sensitivity, specificity, cut-off values), or methodological variations (e.g., protocol conditions or implementation differences).
Key exclusion criteria
Studies will be excluded if they do not involve the mCTSIB, or if the mCTSIB is used only as an outcome measure without evaluating measurement properties, discrimination, prediction, or methodological aspects as a primary aim or primary analysis. Non-original articles, including systematic reviews, narrative reviews, protocols, and editorials, will also be excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Ogawa |
Organization
Shonan Keiiku Hospital
Division name
Division of Rehabilitation
Zip code
252-0816
Address
4360 Endo, Fujisawa-shi, Kanagawa
TEL
0466480050
ogawa.y918@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Ogawa |
Organization
Shonan Keiiku Hospital
Division name
Division of Rehabilitation
Zip code
252-0816
Address
4360 Endo, Fujisawa-shi, Kanagawa
TEL
0466480050
Homepage URL
ogawa.y918@gmail.com
Sponsor or person
Institute
Shonan Keiiku Hospital
Institute
Department
Personal name
Ogawa Yuki
Funding Source
Organization
Shonan Keiiku Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shonan Keiiku Hospital
Address
4360 Endo, Fujisawa-shi, Kanagawa
Tel
0466480050
ogawa.y918@gmail.com
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
| 2026 | Year | 09 | Month | 19 | 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
| 2026 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2027 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is a scoping review of balance assessments using the modified Clinical Test of Sensory Interaction and Balance (mCTSIB). No new observation of or intervention involving human participants will be conducted. Published studies will be reviewed, and data will be charted regarding the study population, setting, mCTSIB protocol (test conditions, support surfaces, visual conditions, measurement devices, outcome variables, and scoring or interpretation methods), measurement properties (reliability, measurement error, validity, and responsiveness), diagnostic or discriminative performance (ROC curves, AUC, sensitivity, specificity, and cut-off values), and comparisons with the Sensory Organization Test (SOT) or other reference and comparator measures. Clinical mCTSIB assessments based on performance time or related clinical outcomes will be distinguished from instrumented mCTSIB assessments using posturography systems, force platforms, wearable sensors, or other devices. The available evidence, methodological variations, and research gaps will be descriptively mapped. Individual participant data will not be collected. If sufficient comparability across studies is identified in terms of the study populations, mCTSIB protocols, and outcomes, a meta-analysis may be conducted, as appropriate, using published aggregate data, such as effect estimates, sample sizes, and measures of variance.
Management information
Registered date
| 2026 | Year | 08 | Month | 31 | Day |
Last modified on
| 2026 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070033
