Ultrasound ImagingNCT04511143
The Correlation Between Ultrasonography Based Muscle Architecture Parameters and Voluntary Isometric Muscle Strength
An observational study of Ultrasound Imaging, run by Istanbul Kültür University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to investigate potential relations of ultrasound-based muscle architecture parameters and isometric knee flexor muscle strength (IKFS) in healthy individuals. IKFS was measured for twenty participants (22.15±2.41 y.o; 8 females, 12 males) by a hand-held dynamometer. Read more about this study
- Who is it for?
- Ages 20 to 28 years
- Conditions the study is for
- Ultrasound Imaging
- What is being tested?
- muscle strength and ultrasound imaging measurement
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2019to 6 Aug 2020
- 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 28 years
- All sexes
- Adult
Study population: Twenty healthy participants (22.15 ± 2.41 y.o; 1.72 ± 0.09 m; 66.5 ± 11.50 kg; 8 female, 12 male) participated in the study.
Who may be able to join
- being healthy young
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Kultur University
Istanbul, E5 Highway Bakırköy, İstanbul, 34158
About this study
Official title: Investigation of the Correlation Between Ultrasonography Based Muscle Architecture Parameters and Maximum Voluntary Isometric Knee Flexor Muscle Strength
The goal of this study is to investigate potential relations of ultrasound-based muscle architecture parameters and isometric knee flexor muscle strength (IKFS) in healthy individuals. IKFS was measured for twenty participants (22.15±2.41 y.o; 8 females, 12 males) by a hand-held dynamometer. Investigated parameters were total and individual cross-sectional areas (CSA), Muscle-Thickness (MT), and pennation-angle (PA) for Biceps Femoris-long head (LBF), Semitendinosus (ST) and Semimembranosus (SM) muscles at 25%, 50% and 75% length of the thigh.
Read the detailed description
The images of hamstring muscles were taken by a US device (Toshiba Aplio 500, Japan) with a linear probe (10-12 MHz, with a footprint of 52 mm).
For each participant, maximum voluntary IKFS was measured from the non-dominant side in the prone position with foot and ankle stayed outside of the bed. Maximum IKFS (20 limbs) was measured by an HHD (A Lafayette Model 01165) (Lafayette, IN) at 15° knee flexion in prone lying position
- Conditions
- Ultrasound Imaging
- Being tested
- muscle strength and ultrasound imaging measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle strength and ultrasound imaging measurementOther
hamstring muscle strenght measured by hand held dynamometer. The long head of Biceps Femoris, Semitendinosus, Semimembronosus were evaluated by B-mode ultrasound imaging.
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between IKFS and ultrasound-based muscle architecture in this study will investigate potential relations of ultrasound-based muscle architecture parameters and isometric knee flexor muscle strength (IKFS) in healthy individuals.
IKFS was measured for twenty participants by a hand-held dynamometer. Investigated parameters were total and individual cross-sectional areas (CSA), Muscle-Thickness (MT), and pennation-angle (PA) for Biceps Femoris-long head (LBF), Semitendinosus (ST) and Semimembranosus (SM) muscles at 25%, 50% and 75% length of the thigh. The association between IKFS and ultrasound-based muscle architecture parameters was assessed.
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start20 Jan 2019
- Primary completion20 May 2019
- Study completion6 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound ImagingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Kültür University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Gülşah Karaca, Istanbul Kültür University
- Investigators
- Nazıf E Akalan, Professor, Principal investigator, Istanbul Kültür UniversityBulent Bayraktar, Professor, Principal investigator, Istanbul UniversitySergen Devran, Researcher, Principal investigator, Istanbul UniversityOmer B Gozubuyuk, M.D.,M.Sc.Dr, Principal investigator, Istanbul UniversityGulsah Karaca, Researcher, Principal investigator, Istanbul Kültür University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511143
- Sponsor's protocol ID
- Istanbul Kultur University
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Correlation Between Ultrasonography Based Muscle Architecture Parameters and Maximum Voluntary Isometric Knee Flexor Muscle Strength
- ClinicalTrials.gov ID
- NCT04511143
- Acronym / sponsor ID
- Istanbul Kultur University
- Conditions
- Ultrasound Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul Kültür UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 13 Aug 2020 (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.
The goal of this study is to investigate potential relations of ultrasound-based muscle architecture parameters and isometric knee flexor muscle strength (IKFS) in healthy individuals. IKFS was measured for twenty participants (22.15±2.41 y.o; 8 females, 12 males) by a hand-held dynamometer. Investigated parameters were total and individual cross-sectional areas (CSA), Muscle-Thickness (MT), and pennation-angle (PA) for Biceps Femoris-long head (LBF), Semitendinosus (ST) and Semimembranosus (SM) muscles at 25%, 50% and 75% length of the thigh.
Detailed description
The images of hamstring muscles were taken by a US device (Toshiba Aplio 500, Japan) with a linear probe (10-12 MHz, with a footprint of 52 mm).
For each participant, maximum voluntary IKFS was measured from the non-dominant side in the prone position with foot and ankle stayed outside of the bed. Maximum IKFS (20 limbs) was measured by an HHD (A Lafayette Model 01165) (Lafayette, IN) at 15° knee flexion in prone lying position
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 28 years
- Sex
- All
- Age groups
- Adult
- Study population
- Twenty healthy participants (22.15 ± 2.41 y.o; 1.72 ± 0.09 m; 66.5 ± 11.50 kg; 8 female, 12 male) participated in the study.
Key inclusion criteria (1 listed)
- being healthy young
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| muscle strength and ultrasound imaging measurementhamstring muscle strenght measured by hand held dynamometer. The long head of Biceps Femoris, Semitendinosus, Semimembronosus were evaluated by B-mode ultrasound imaging. | Other | – |
Primary outcome
The association between IKFS and ultrasound-based muscle architecture in this study will investigate potential relations of ultrasound-based muscle architecture parameters and isometric knee flexor muscle strength (IKFS) in healthy individuals.
Time frame: an average of 1 year
IKFS was measured for twenty participants by a hand-held dynamometer. Investigated parameters were total and individual cross-sectional areas (CSA), Muscle-Thickness (MT), and pennation-angle (PA) for Biceps Femoris-long head (LBF), Semitendinosus (ST) and Semimembranosus (SM) muscles at 25%, 50% and 75% length of the thigh. The association between IKFS and ultrasound-based muscle architecture parameters was assessed.
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 13 Aug 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Ultrasound Imaging
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
RecruitingObservational study
Conventional Ultrasound Versus Remote Ultraportable ulTrasound in the Context of Viral Hepatitis
Hepatitis, Teleradiology
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.
Nazıf E Akalan, Professor principal investigator
Istanbul Kültür University
Bulent Bayraktar, Professor principal investigator
Istanbul University
Sergen Devran, Researcher principal investigator
Istanbul University
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 Ultrasound Imaging, run by Istanbul Kültür University at 1 site 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 1 inclusion and 1 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 13 Aug 2020. 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 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?
The association between IKFS and ultrasound-based muscle architecture in this study will investigate potential relations of ultrasound-based muscle architecture parameters and isometric knee flexor muscle strength (IKFS) in healthy individuals. (time frame: an average of 1 year). 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 13 Aug 2020.