Healthy AdultsNCT03733613
Reliability and Validity of Kinect Detector for Fitness Tests and Gait Performance Analysis
An observational study of Healthy Adults, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2018to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy adults
Who may be able to join
- healthy adults
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang-Ming University
Taipei
Yea-Ru Yang, PhD, +886228267279, yryang@ym.edu.tw
Yea-Ru Yang, PhD
About this study
Official title: To Verify the Reliability and Validity of Kinect Detector While Apply to Physical Fitness Tests and Gait Performance Analysis
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.
Read the detailed 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.
- Conditions
- Healthy Adults
- Being tested
- no intervention
- Keywords
- Kinect, somatosensory detector, physical fitness, gait analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Subjects will receive pre and post-test, in order to verify the test-retest reliability of the Somatosensory detector Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Gait speed is calculated using distance in meters and time in seconds.
Measured: Change from baseline at one week
Gait cadence
Cadence is the rate at which a person walk, expressed in steps per minute.
Measured: Change from baseline at one week
Gait stride length
The stride length is the distance between two successive placements of the same foot.
Measured: Change from baseline at one week
Secondary outcomes (6)
One leg standing test
To test balance ability
Measured: Change from baseline at one week
Functional forward reach test
To test functional balance performance
Measured: Change from baseline at one week
Timed up and go test
To test functional balance performance
Measured: Change from baseline at one week
Upper arm curl test
To test functional muscle strength of upper extremities
Measured: Change from baseline at one week
30 seconds sit-stand-sit test
To test functional muscle strength of lower extremities
Measured: Change from baseline at one week
2 minutes stepping test
To test cardiopulmonary ability
Measured: Change from baseline at one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Nov 2018
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733613
- Sponsor's protocol ID
- YM106054E
- Status last verified
- Jul 2019
- First submitted
- 31 Oct 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Verify the Reliability and Validity of Kinect Detector While Apply to Physical Fitness Tests and Gait Performance Analysis
- ClinicalTrials.gov ID
- NCT03733613
- Acronym / sponsor ID
- YM106054E
- Conditions
- Healthy Adults
- Keywords
- Kinect, somatosensory detector, physical fitness, gait analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Other: no interventionSubjects will receive pre and post-test, in order to verify the test-retest reliability of the Somatosensory detector |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy adults
Key inclusion criteria (1 listed)
- healthy adults
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Healthy adults |
Primary outcome
Gait speed
Time frame: Change from baseline at one week
Gait speed is calculated using distance in meters and time in seconds.
Gait cadence
Time frame: Change from baseline at one week
Cadence is the rate at which a person walk, expressed in steps per minute.
Gait stride length
Time frame: Change from baseline at one week
The stride length is the distance between two successive placements of the same foot.
6 secondary outcomes
One leg standing test
Time frame: Change from baseline at one week
Functional forward reach test
Time frame: Change from baseline at one week
Timed up and go test
Time frame: Change from baseline at one week
Upper arm curl test
Time frame: Change from baseline at one week
30 seconds sit-stand-sit test
Time frame: Change from baseline at one week
2 minutes stepping test
Time frame: Change from baseline at one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adults, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yea-Ru Yang, Ph.D. (+88628267279, yryang@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: Change from baseline at one week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.