NCT06674083

Brief Summary

The aim of the study is to examine the Gyko inertial sensor system in healthy adults. In the study, jump and postural control parameters are assessed with a one-week interval. To evaluate intra-rater reliability, ICC, SEM, and MDC values will be calculated.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 3, 2024

Last Update Submit

November 4, 2024

Conditions

Keywords

Gyko inertial sensor systemJumpReliabilityPostural stability

Outcome Measures

Primary Outcomes (1)

  • The reliability of the jump and postural stability reliability with Gyko inertial system

    Assessments will be repeated one week apart to evaluate the reliability of the Gyko inertial system in postural stability and jump performance parameters. Jump and postural stability assessment with Gyko inertial system.

    two weeks

Study Arms (1)

Healthy adults

Inclusion criteria for participants are as follows: being between the ages of 18 and 30, having no balance issues (such as vertigo) that could affect assessments, and having no health problems that would interfere with understanding the assessments.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Sample size calculations were based on the ICC (0.81-0.87) data for jump parameters obtained from the reference study. Accordingly, the minimum acceptable reliability (ICC) (ρ0) was set at 0.70, with the expected reliability (ICC) (ρ1) at 0.85, considering 80% power and a significance level of 0.05. As a result of the power analysis, it was determined that at least 50 participants should be included in the study. Considering a 10% possibility of separation in test-retest for the participants, it was decided to include 55 individuals.

You may qualify if:

  • being between the ages of 18 and 35
  • having no balance issues (such as vertigo) that could affect assessments
  • having no health problems that would interfere with understanding the assessments.

You may not qualify if:

  • Having known neurological, rheumatological, or musculoskeletal system problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 5, 2024

Study Start

February 1, 2025

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

November 6, 2024

Record last verified: 2024-11