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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03733613
Other study ID # YM106054E
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date October 31, 2019

Study information

Verified date July 2019
Source National Yang Ming University
Contact Yea-Ru Yang, Ph.D.
Phone +88628267279
Email yryang@ym.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: Depending on nature and needs, physical fitness can be divided into healthy fitness and physical fitness (also known as competitive fitness). Healthy fitness includes cardio-respiratory fitness, muscle fitness, muscular endurance, flexibility, and body composition. Physical fitness includes coordination, speed, explosiveness, balance, agility, and reaction time. Although the monitoring of fitness is very important, most of the tests need to be assisted by professionally trained fitness inspectors, so that the public who wants to regularly check their fitness status will facing a dilemma-- insufficient of inspectors. In the face of such a situation, the somatosensory detector may be a choice which is relatively objective, convenient and no need to rely on the inspectors. Therefore, the validity and retest reliability of the somatosensory detector need to be verified in order to achieve accurate and objective measurement results.


Description:

Background: Depending on nature and needs, physical fitness can be divided into healthy fitness and physical fitness (also known as competitive fitness). Healthy fitness includes cardio-respiratory fitness, muscle fitness, muscular endurance, flexibility, and body composition. Physical fitness includes coordination, speed, explosiveness, balance, agility, and reaction time. Although the monitoring of fitness is very important, most of the tests need to be assisted by professionally trained fitness inspectors, so that the public who wants to regularly check their fitness status will facing a dilemma-- insufficient of inspectors. In the face of such a situation, the somatosensory detector may be a choice which is relatively objective, convenient and no need to rely on the inspectors. Therefore, the validity and retest reliability of the somatosensory detector need to be verified in order to achieve accurate and objective measurement results.

Research purposes: To verify the retest reliability and validity of the somatosensory detector on physical fitness and gait performance.

Methods: The trial will enroll 60 subjects, 30 of them were healthy individuals between the ages of 20 and 65, and 30 are healthy elderly than 65 years of age. The exclusion criteria including: (1) those who are unable to follow the instructions and who have orthopedic, nervous system or cardiopulmonary system disorders, or who have abnormal gait pattern, or who are affected by the above physiological system disorders. Subjects will receive two tests, there's a one-week interval between each test. In the first test, the fitness assessment of the fitness inspector and the somatosensory detector was performed simultaneously, and the fitness evaluation of the somatosensory detector was performed only for the second time. And use statistical software to analyze the reliability and validity of the somatosensory detector.

Statistical Analysis: Using SPSS 20.0 for data archiving and statistical analysis, the reliability and validity of the test will be detected by intraclass correlation one-way random model, and presenting by the intraclass correlation coefficient and 95% confidence interval.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- healthy adults

Exclusion Criteria:

- those unable to follow to instructions

- those have abnormal gait pattern which caused by orthopedics system disorders, nervous system disorders or cardio-respiratory disorders

- those with abnormal movement performance which caused by physiological system obstacles

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
Taiwan National Yang-Ming University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gait speed Gait speed is calculated using distance in meters and time in seconds. Change from baseline at one week
Primary Gait cadence Cadence is the rate at which a person walk, expressed in steps per minute. Change from baseline at one week
Primary Gait stride length The stride length is the distance between two successive placements of the same foot. Change from baseline at one week
Secondary One leg standing test To test balance ability Change from baseline at one week
Secondary Functional forward reach test To test functional balance performance Change from baseline at one week
Secondary Timed up and go test To test functional balance performance Change from baseline at one week
Secondary Upper arm curl test To test functional muscle strength of upper extremities Change from baseline at one week
Secondary 30 seconds sit-stand-sit test To test functional muscle strength of lower extremities Change from baseline at one week
Secondary 2 minutes stepping test To test cardiopulmonary ability Change from baseline at one week
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