Mobility LimitationNCT04737226
The Relation of Ankle Mobility and Achilles Tendon, Plantar Fascia and Iliotibial Band Mechanical Properties
A study testing myotonometric assessment and Ankle mobility assessment in people with Mobility Limitation and Stiffness of Right Ankle, Not Elsewhere Classified, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The myotonometric assessment is becoming popular and important in athletic population. It is mentioned an alternate method than expensive methods, and it is easy and reliable assessment. Still there is not enough information of mechanical characteristics in athletic population and ankle mobility. Read more about this study
- Who is it for?
- Ages 18 to 38 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation, Stiffness of Right Ankle, Not Elsewhere Classified, Stiffness of Left Ankle, Not Elsewhere Classified
- What is being tested?
- myotonometric assessment and Ankle mobility assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2020to 9 Sep 2021
- 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 38 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being a professional athlete
- right dominant
- not having any lower extremity injury or surgery in the last 6 months,
- following routine training program.
Who cannot join
- a history of strain or surgery with knee or ankle,
- had any neurological or systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Ankle Mobility and Achilles Tendon, Plantar Fascia, Iliotibial Band Stiffness and Elasticity in Athletes
The myotonometric assessment is becoming popular and important in athletic population. It is mentioned an alternate method than expensive methods, and it is easy and reliable assessment. Still there is not enough information of mechanical characteristics in athletic population and ankle mobility. Most clinicians or trainers can use this results and technique for enhancing performance, rehabilitation or prevention
Read the detailed description
The soft tissue mechanical properties can be assessed through elastography and ultrasonography. Both methods can measure passive and active soft tissue properties. These methods are the gold standard to measure stiffness and elasticity, but they are expensive, operator dependent and need a laboratory settings.Recently, myotonometric device has been used to measure the mechanical properties of the muscles and tendons. This method serves many advantages, such as non-invasive, painless and cost-effective. There is an increasing literature on athletic training about how training effects viscoelastic properties. However, to the best of our knowledge, there were no studies assessing stiffness and elasticity of AT, PF and ITB and the relation with ankle mobility in different sport disciplines. The purpose of this study were to demonstrate the mechanical properties of AT, PF and ITB and find out relation with restricted ankle mobility in athletes.
- Conditions
- Mobility Limitation, Stiffness of Right Ankle, Not Elsewhere Classified, Stiffness of Left Ankle, Not Elsewhere Classified, Tone Increased, Muscle
- Being tested
- myotonometric assessment, Ankle mobility assessment
- Keywords
- Stiffness, Tone, Elasticity, Ankle mobility
- Medical subject headings
- Mobility Limitation, Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myotonometric assessmentDiagnostic test
The measurement method of the device is based on the free oscillation technique. Firstly, the probe of the device is placed perpendicular to the skin and a pre-pressure is applied to compress the subcutaneous tissue. Then, a short mechanical impulse is applied, causing damped oscillation on the tissue and the co-oscillation is recorded by an accelerometer.
Ankle mobility assessmentDiagnostic test
The knee to wall lunge test will use in a standing position while the heel in contact with the ground and the knee was in line with second toe. Athletes will do lunge forward and inclinometer will be place at the middle anterior tibial crista and measurement will be record.
| Study group | Role | What they receive |
|---|---|---|
| Basketballers | Experimental | Not described Receives: Diagnostic Test: myotonometric assessment; Diagnostic Test: Ankle mobility assessment |
| Volleyballers | Experimental | Not described Receives: Diagnostic Test: myotonometric assessment; Diagnostic Test: Ankle mobility assessment |
| Runners | Experimental | Not described Receives: Diagnostic Test: myotonometric assessment; Diagnostic Test: Ankle mobility assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stiffness obtained from myotonometric assessment
Myoton device stimulations create natural oscillations in the tissue and records these oscillations using an accelerometer. Stiffness (N/m) is calculated by device.
Measured: through study completion, an average of 8 weeks
Elasticity obtained from myotonometric assessment
Myoton device stimulations create natural oscillations in the tissue and records these oscillations using an accelerometer. Elasticity (log) is calculated by device.
Measured: through study completion, an average of 8 weeks
Ankle range of motion
Inclinometer is be place at the middle anterior tibial crista during the knee to wall test. The angle of incliometer during a maximum distance between the largest toe and the wall that is recorded for ankle range of motion.
Measured: through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start12 Dec 2020
- Primary completion12 Jul 2021
- Study completion9 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Professional male athletes (basketballers, voleyballers, runners) will participate and divided to groups. AT, PF and ITB mechanical properties will evaluate with MyotonPro device (Myoton Ltd, Estonia). Ankle mobility will measure with inclinometer during a knee to wall lunge test.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Usgu, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737226
- Sponsor's protocol ID
- 2020/100
- Status last verified
- Mar 2022
- First submitted
- 20 Jan 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cristi-Sanchez I, Danes-Daetz C, Neira A, Ferrada W, Yanez Diaz R, Silvestre Aguirre R. Patellar and Achilles Tendon Stiffness in Elite Soccer Players Assessed Using Myotonometric Measurements. Sports Health. 2019 Mar/Apr;11(2):157-162. doi: 10.1177/1941738118820517. Epub 2019 Jan 2.
PubMed 30601077Gavronski G, Veraksits A, Vasar E, Maaroos J. Evaluation of viscoelastic parameters of the skeletal muscles in junior triathletes. Physiol Meas. 2007 Jun;28(6):625-37. doi: 10.1088/0967-3334/28/6/002. Epub 2007 May 3.
PubMed 17664617Kubo K, Miyazaki D, Shimoju S, Tsunoda N. Relationship between elastic properties of tendon structures and performance in long distance runners. Eur J Appl Physiol. 2015 Aug;115(8):1725-33. doi: 10.1007/s00421-015-3156-2. Epub 2015 Mar 27.
PubMed 25813019Liu CL, Li YP, Wang XQ, Zhang ZJ. Quantifying the Stiffness of Achilles Tendon: Intra- and Inter-Operator Reliability and the Effect of Ankle Joint Motion. Med Sci Monit. 2018 Jul 14;24:4876-4881. doi: 10.12659/MSM.909531.
PubMed 30006997Pozarowszczyk B, Pawlaczyk W, Smoter M, Zarzycki A, Mroczek D, Kumorek M, Witkowski K, Adam K. Effects of Karate Fights on Achilles Tendon Stiffness Measured by Myotonometry. J Hum Kinet. 2017 Mar 12;56:93-97. doi: 10.1515/hukin-2017-0026. eCollection 2017 Feb.
PubMed 28469747
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Ankle Mobility and Achilles Tendon, Plantar Fascia, Iliotibial Band Stiffness and Elasticity in Athletes
- ClinicalTrials.gov ID
- NCT04737226
- Acronym / sponsor ID
- 2020/100
- Conditions
- Mobility Limitation, Stiffness of Right Ankle, Not Elsewhere Classified, Stiffness of Left Ankle, Not Elsewhere Classified, Tone Increased, Muscle
- Keywords
- Stiffness, Tone, Elasticity, Ankle mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 3 Feb 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.
The myotonometric assessment is becoming popular and important in athletic population. It is mentioned an alternate method than expensive methods, and it is easy and reliable assessment. Still there is not enough information of mechanical characteristics in athletic population and ankle mobility. Most clinicians or trainers can use this results and technique for enhancing performance, rehabilitation or prevention
Detailed description
The soft tissue mechanical properties can be assessed through elastography and ultrasonography. Both methods can measure passive and active soft tissue properties. These methods are the gold standard to measure stiffness and elasticity, but they are expensive, operator dependent and need a laboratory settings.Recently, myotonometric device has been used to measure the mechanical properties of the muscles and tendons. This method serves many advantages, such as non-invasive, painless and cost-effective. There is an increasing literature on athletic training about how training effects viscoelastic properties. However, to the best of our knowledge, there were no studies assessing stiffness and elasticity of AT, PF and ITB and the relation with ankle mobility in different sport disciplines. The purpose of this study were to demonstrate the mechanical properties of AT, PF and ITB and find out relation with restricted ankle mobility in athletes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Professional male athletes (basketballers, voleyballers, runners) will participate and divided to groups. AT, PF and ITB mechanical properties will evaluate with MyotonPro device (Myoton Ltd, Estonia). Ankle mobility will measure with inclinometer during a knee to wall lunge test.
| Arm | Type | Receives |
|---|---|---|
| Basketballers | Experimental | Diagnostic Test: myotonometric assessment, Diagnostic Test: Ankle mobility assessment |
| Volleyballers | Experimental | Diagnostic Test: myotonometric assessment, Diagnostic Test: Ankle mobility assessment |
| Runners | Experimental | Diagnostic Test: myotonometric assessment, Diagnostic Test: Ankle mobility assessment |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- being a professional athlete
- right dominant
- not having any lower extremity injury or surgery in the last 6 months,
- following routine training program.
Key exclusion criteria (2 listed)
- a history of strain or surgery with knee or ankle,
- had any neurological or systemic disease.
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 |
|---|---|---|
| myotonometric assessmentThe measurement method of the device is based on the free oscillation technique. Firstly, the probe of the device is placed perpendicular to the skin and a pre-pressure is applied to compress the subcutaneous tissue. Then, a short mechanical impulse is applied, causing damped oscillation on the tissue and the co-oscillation is recorded by an accelerometer. | Diagnostic test | Basketballers, Runners, Volleyballers |
| Ankle mobility assessmentThe knee to wall lunge test will use in a standing position while the heel in contact with the ground and the knee was in line with second toe. Athletes will do lunge forward and inclinometer will be place at the middle anterior tibial crista and measurement will be record. | Diagnostic test | Basketballers, Runners, Volleyballers |
Primary outcome
Stiffness obtained from myotonometric assessment
Time frame: through study completion, an average of 8 weeks
Myoton device stimulations create natural oscillations in the tissue and records these oscillations using an accelerometer. Stiffness (N/m) is calculated by device.
Elasticity obtained from myotonometric assessment
Time frame: through study completion, an average of 8 weeks
Myoton device stimulations create natural oscillations in the tissue and records these oscillations using an accelerometer. Elasticity (log) is calculated by device.
Ankle range of motion
Time frame: through study completion, an average of 8 weeks
Inclinometer is be place at the middle anterior tibial crista during the knee to wall test. The angle of incliometer during a maximum distance between the largest toe and the wall that is recorded for ankle range of motion.
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 16 Mar 2022.
- Background: PubMed 30601077Cristi-Sanchez I, Danes-Daetz C, Neira A, Ferrada W, Yanez Diaz R, Silvestre Aguirre R. Patellar and Achilles Tendon Stiffness in Elite Soccer Players Assessed Using Myotonometric Measurements. Sports Health. 2019 Mar/Apr;11(2):157-162. doi: 10.1177/1941738118820517. Epub 2019 Jan 2.
- Background: PubMed 17664617Gavronski G, Veraksits A, Vasar E, Maaroos J. Evaluation of viscoelastic parameters of the skeletal muscles in junior triathletes. Physiol Meas. 2007 Jun;28(6):625-37. doi: 10.1088/0967-3334/28/6/002. Epub 2007 May 3.
- Background: PubMed 25813019Kubo K, Miyazaki D, Shimoju S, Tsunoda N. Relationship between elastic properties of tendon structures and performance in long distance runners. Eur J Appl Physiol. 2015 Aug;115(8):1725-33. doi: 10.1007/s00421-015-3156-2. Epub 2015 Mar 27.
- Background: PubMed 30006997Liu CL, Li YP, Wang XQ, Zhang ZJ. Quantifying the Stiffness of Achilles Tendon: Intra- and Inter-Operator Reliability and the Effect of Ankle Joint Motion. Med Sci Monit. 2018 Jul 14;24:4876-4881. doi: 10.12659/MSM.909531.
- Background: PubMed 28469747Pozarowszczyk B, Pawlaczyk W, Smoter M, Zarzycki A, Mroczek D, Kumorek M, Witkowski K, Adam K. Effects of Karate Fights on Achilles Tendon Stiffness Measured by Myotonometry. J Hum Kinet. 2017 Mar 12;56:93-97. doi: 10.1515/hukin-2017-0026. eCollection 2017 Feb.
- Individual participant dataSharing planned: No
Related trials for Mobility Limitation
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Recruiting
Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort
Joint Osteoarthritis, Atherosclerosis of the Distal Arteries, Without Gangrene
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingObservational study
Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
Tendinopathy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myotonometric assessment and Ankle mobility assessment in people with Mobility Limitation and Stiffness of Right Ankle, Not Elsewhere Classified, run by Hasan Kalyoncu 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 4 inclusion and 2 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 16 Mar 2022. 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?
Stiffness obtained from myotonometric assessment (time frame: through study completion, an average of 8 weeks). 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?
On the ClinicalTrials.gov record for NCT04737226, which also lists 5 linked publications.
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 16 Mar 2022.