HealthyNCT04695574
The Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST): A New Clinical Performance Test
A study testing Some clinical evaluation performance tests together with procedure of Closed Kinetic Chain Lower Extremity Stability Test in people with Healthy, run by Gazi University at 2 sites in Turkey (Türkiye).
Trial summary
It becomes important to evaluate closed kinetic chain activity. The aim of this study was to develop and to determine the test-retest, intra- and interreliability, and validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Some clinical evaluation performance tests together with procedure of Closed Kinetic Chain Lower Extremity Stability Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Apr 2019to 15 Apr 2020
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals who healthy adults,
- Volunteer
Who cannot join
- Surgery last six months and pain,
- Disability,
- Instability,
- Limited range of motion in knee function,
- Chronic diseases
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gazi University
Ankara, 06500
Halime ARIKAN
Ankara, Çankaya, 06490
About this study
Official title: Development, Reliability and Validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST): A New Clinical Performance Test
It becomes important to evaluate closed kinetic chain activity. The aim of this study was to develop and to determine the test-retest, intra- and interreliability, and validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST).
Read the detailed description
Closed kinetic chain activities and exercises are used more and more in rehabilitation programs as they take place in daily life as functional movements. Therefore, it becomes important to evaluate closed kinetic chain activity. The aim of this study is to develop and to determine the test-retest, intra- and interreliability, and validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST). Three-blinded, cross-sectional, repeated-measures clinical measurement reliability trial. To assess the reliability of CKCLEST, intraclass correlation coefficient (ICC), standard error of measurement (SEM), minimal detectable change (MDC), and Bland-Altman plot will be used. For concurrent validity of CKCLEST will be applied Spearman correlation analysis with Vertical Jump Test, Isokinetic Dynamometer Test, Single Leg Hop Test, and Prone Bridge Test. All analyses were made for both the best score and the average score. This test allows the evaluation of functional lower extremity stability, static/dynamic control of the lower extremity (knee/hip) or trunk, and simultaneous activation of the quadriceps and hamstring muscles / such coactivation.
- Conditions
- Healthy
- Being tested
- Some clinical evaluation performance tests together with procedure of Closed Kinetic Chain Lower Extremity Stability Test
- Keywords
- Endurance, Lower limb, Performance test, Power, Reliability and Validity, Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Some clinical evaluation performance tests together with procedure of Closed Kinetic Chain Lower Extremity Stability TestProcedure or surgery
Also called Vertical Jump Test, Isokinetic Dynamometer Test, Single Leg Hop Test, Prone Bridge Test
Clinical evaluation methods
| Study group | Role | What they receive |
|---|---|---|
| Volunteer young adults | Experimental | Healthy young adults Receives: Procedure: Some clinical evaluation performance tests together with procedure of Closed Kinetic Chain Lower Extremity Stability Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the concurrent validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST)
For concurrent validity of CKCLEST was applied Spearman correlation analysis with Vertical Jump Test, Isokinetic Dynamometer Test, Single Leg Hop Test, and Prone Bridge Test.
Measured: 45 minutes
Secondary outcomes (1)
To determine the the test-retest, intra- and interrater reliability of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST)
To assess the reliability of CKCLEST, it was applied twice.
Measured: 4 minutes, 7-14 days apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start15 Apr 2019
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Three-blinded, cross-sectional, repeated-measures clinical measurement reliability trial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime ARIKAN, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695574
- Sponsor's protocol ID
- 2019-029
- Status last verified
- Jan 2021
- First submitted
- 1 Jan 2021
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study does not contain any patient records and numbers. Individuals are healthy and they filled out the informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Reliability and Validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST): A New Clinical Performance Test
- ClinicalTrials.gov ID
- NCT04695574
- Acronym / sponsor ID
- 2019-029
- Conditions
- Healthy
- Keywords
- Endurance, Lower limb, Performance test, Power, Reliability and Validity, Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 5 Jan 2021 (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.
It becomes important to evaluate closed kinetic chain activity. The aim of this study was to develop and to determine the test-retest, intra- and interreliability, and validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST).
Detailed description
Closed kinetic chain activities and exercises are used more and more in rehabilitation programs as they take place in daily life as functional movements. Therefore, it becomes important to evaluate closed kinetic chain activity. The aim of this study is to develop and to determine the test-retest, intra- and interreliability, and validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST). Three-blinded, cross-sectional, repeated-measures clinical measurement reliability trial. To assess the reliability of CKCLEST, intraclass correlation coefficient (ICC), standard error of measurement (SEM), minimal detectable change (MDC), and Bland-Altman plot will be used. For concurrent validity of CKCLEST will be applied Spearman correlation analysis with Vertical Jump Test, Isokinetic Dynamometer Test, Single Leg Hop Test, and Prone Bridge Test. All analyses were made for both the best score and the average score. This test allows the evaluation of functional lower extremity stability, static/dynamic control of the lower extremity (knee/hip) or trunk, and simultaneous activation of the quadriceps and hamstring muscles / such coactivation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Three-blinded, cross-sectional, repeated-measures clinical measurement reliability trial
| Arm | Type | Receives |
|---|---|---|
| Volunteer young adults | Experimental | Procedure: Some clinical evaluation performance tests together with procedure of Closed Kinetic Chain Lower Extremity Stability TestHealthy young adults |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Individuals who healthy adults,
- Volunteer
Key exclusion criteria (5 listed)
- Surgery last six months and pain,
- Disability,
- Instability,
- Limited range of motion in knee function,
- Chronic diseases
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 |
|---|---|---|
| Some clinical evaluation performance tests together with procedure of Closed Kinetic Chain Lower Extremity Stability TestAlso: Vertical Jump Test, Isokinetic Dynamometer Test, Single Leg Hop Test, Prone Bridge TestClinical evaluation methods | Procedure or surgery | Volunteer young adults |
Primary outcome
To determine the concurrent validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST)
Time frame: 45 minutes
For concurrent validity of CKCLEST was applied Spearman correlation analysis with Vertical Jump Test, Isokinetic Dynamometer Test, Single Leg Hop Test, and Prone Bridge Test.
1 secondary outcome
To determine the the test-retest, intra- and interrater reliability of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST)
Time frame: 4 minutes, 7-14 days apart.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No. The study does not contain any patient records and numbers. Individuals are healthy and they filled out the informed consent form.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Some clinical evaluation performance tests together with procedure of Closed Kinetic Chain Lower Extremity Stability Test in people with Healthy, run by Gazi University at 2 sites in Turkey (Türkiye).
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the concurrent validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST) (time frame: 45 minutes). 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 5 Jan 2021.