Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001001583
Ethics application status
Approved
Date submitted
9/05/2024
Date registered
16/08/2024
Date last updated
16/08/2024
Date data sharing statement initially provided
16/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of standards for the Biodex Biosway stabilometric platform using anthropometric measurements from young, healthy volunteers
Scientific title
Development of standards for the Biodex Biosway stabilometric platform using anthropometric and postural stability data from young, healthy volunteers
Secondary ID [1] 312118 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 333760 0
postural instability 333761 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330439 330439 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. Obtaining standards (normative values) for a commonly used postural stability diagnostic tool
2. Diagnostics of the musculoskeletal system are within the competences and responsibilities of a physiotherapist. One of the areas subject to frequent diagnostics is postural stability. A commonly used tool for such diagnostics is the Biodex Biosway platform, which enables the assessment of postural stability on a hard and soft surface and with eyes open and closed. The Biodex Bisway platform is a reliable, easy-to-use tool that allows you to obtain many useful indicators in the diagnosis of both children and adults. However, despite these advantages, the platform does not have standards, only average values. The development of standards would allow for more reliable patient diagnosis and would be very useful in developing the results of scientific research.
3. Participants: about 500 young healthy presons, aged between 19 – 24 years, both sexes, who gave informed consent to participate in the project.
4. Procedure:
• Measurement of body height - Martin type anthropometer, measurement accuracy up to 0.1 cm, measurement from the vertex point to the basis point, in a standing position, bare feet
• Body weight measurement - Tanita scale, measurement accuracy up to 0.1 kg, measurement method - bioelectrical impedance, bare feet
• Measurement of postural stability - Biosway stabilometric platform by Biodex, measurement with 3 tests: Postural Stability Test (PST) - measurement on a hard surface; Limits of Stability Test (LOS) – measurement on a hard surface; the Modified Clinical Test of Sensory Interaction on Balance (FRT M-CTSIB) – measurement on a hard and soft surface; bare feet. Each patient will be assess only once, duration of the single examination – about 5 – 7 minutes.
5. Provider of all examinations - physiotherapist (professor degree)
6. Model of delivery: face to face
7. Type of location where the examination occurred - Central Research and Development Laboratory, University of Physical Education in Krakow, Poland
Intervention code [1] 328556 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338192 0
Measurement of postural stability - Biosway stabilometric platform by Biodex - postural stability
Timepoint [1] 338192 0
one-time measurement
Primary outcome [2] 338193 0
Measurement of postural stability - Biosway stabilometric platform by Biodex - limits of stability
Timepoint [2] 338193 0
one-time measurement
Primary outcome [3] 338194 0
Measurement of postural stability - Biosway stabilometric platform by Biodex - risk of falls
Timepoint [3] 338194 0
one-time measurement
Secondary outcome [1] 434890 0
Measurement of body height - Martin type anthropometer,
Timepoint [1] 434890 0
one-time measurement
Secondary outcome [2] 437363 0
Body weight measurement - Tanita scale
Timepoint [2] 437363 0
one-time measurement

Eligibility
Key inclusion criteria
About 500 young healthy presons, aged between 19 – 24 years, both sexes, who gave informed consent to participate in the project.
Minimum age
19 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Injuries to the musculoskeletal system up to 12 months before participating in the study; dizziness up to 3 days before participating in the study; headaches on the day of the examination; pain in the musculoskeletal system up to 3 days before the examination

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/10/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 26296 0
Poland
State/province [1] 26296 0
Malopolska Voivodship

Funding & Sponsors
Funding source category [1] 316475 0
Self funded/Unfunded
Name [1] 316475 0
Country [1] 316475 0
Primary sponsor type
Individual
Name
Aneta Bac, University of Physical Education in Krakow, Poland
Address
Country
Poland
Secondary sponsor category [1] 318650 0
None
Name [1] 318650 0
Address [1] 318650 0
Country [1] 318650 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315268 0
Bioethics Committee of the Tarnów University
Ethics committee address [1] 315268 0
Ethics committee country [1] 315268 0
Poland
Date submitted for ethics approval [1] 315268 0
11/03/2024
Approval date [1] 315268 0
17/04/2024
Ethics approval number [1] 315268 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134178 0
Prof Aneta Bac
Address 134178 0
University of Physical Education in Krakow Institute of Applied Science al. Jana Pawla II 7831-571 Krakow, Poland
Country 134178 0
Poland
Phone 134178 0
+48 12 683 13 70
Fax 134178 0
Email 134178 0
[email protected]
Contact person for public queries
Name 134179 0
Aneta Bac
Address 134179 0
University of Physical Education in Krakow Institute of Applied Science al. Jana Pawla II 7831-571 Krakow, Poland
Country 134179 0
Poland
Phone 134179 0
+48 12 683 13 70
Fax 134179 0
Email 134179 0
[email protected]
Contact person for scientific queries
Name 134180 0
Aneta Bac
Address 134180 0
University of Physical Education in Krakow Institute of Applied Science al. Jana Pawla II 7831-571 Krakow, Poland
Country 134180 0
Poland
Phone 134180 0
+48 12 683 13 70
Fax 134180 0
Email 134180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.