Achilles Tendon ThicknessNCT05976542
The Relationship Between Plantar Fascia and Achilles Tendon Thickness Asymmetry and Spatio-temporal Parameters of Gait
An observational study of Achilles Tendon Thickness and Plantar Fascia Thickness, run by Hacettepe University.
Trial summary
There are studies on loading the foot with an increase in the thickness of the Plantar Fascia and Achilles Tendon. However, no study was found that evaluated the relationship between morphological features such as plantar fascia and Achilles tendon thickness and spatio-temporal parameters of gait in healthy… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendon Thickness, Plantar Fascia Thickness, Spatio-temporal Parameteres of Gait
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2023to 5 Oct 2023
- How long will I take part?
- 1 Week
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adult volunteers aged 20-40 will participate in the research.
Who may be able to join
- Being physically healthy (No symptoms or complaints at the moment, and no disease or trauma affecting the musculoskeletal system in the last 6 months)
- Being 20-40 years old
- Body Mass Index (BMI) being within the limits accepted as normal (18.5-24.9kg/m2) according to the World Health Organization (WHO)
- Classification of foot type as normal (API score= 0 to +5) as a result of the evaluation made with the Foot Posture Index (API) (38)
- Not having done any compelling (jogging, walking, weight or resistance training, yoga, pilates, aerobics, collective exercise sessions such as stepping…) exercises and activities in the last 2 days before the evaluation.
Who cannot join
- Disease or problems that may affect walking (plantar fasciitis, having to use walking aids, visual or hearing impairment, other problems related to the lower extremities or spine)
- Having undergone orthopedic trauma or surgery involving the lower extremity
- Having symptoms of severe shortness of breath or intolerance of walking while walking
- Person; have a medical history that may indicate an increased risk of falling, such as fainting of unknown cause, blood sugar imbalance, unstable low or high blood pressure
- Congenital (pes planus, pes cavus, pes equinovarus, vertical talus, etc.) or acquired (pes planus and planovalgus, pes cavus, other deformities associated with foot arches…) foot deformity defined by clinical evaluation
- Presence of cardiovascular, neurological or musculoskeletal orthopedic or rheumatological disease or systemic disease associated with diabetes, connective tissue disorder
- In addition, hypoechoic areas, perifascial fluid, and plantar fascia thickness measuring more than 4 mm during ultrasound imaging (39).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of the Relationship Between Plantar Fascia and Achilles Tendon Thickness Asymmetry and Spatio-temporal Parameters of Gait in Healthy Individuals
There are studies on loading the foot with an increase in the thickness of the Plantar Fascia and Achilles Tendon.
However, no study was found that evaluated the relationship between morphological features such as plantar fascia and Achilles tendon thickness and spatio-temporal parameters of gait in healthy individuals.
Read more
In this study, it is aimed to investigate the relationship between the asymmetry in the thickness of the plantar fascia and Achilles tendon and the asymmetry in the spati-temporal parameters of gait.
Healthy adult volunteers aged 20-40 will participate in the research. Demographic data of the participants will be recorded in the study. Following this, a clinical evaluation of the foot and ankle will be made. The Optogait Photoelectric Cell System (Microgate, Bolzano, Italy) device will be used to record the spatio-temporal parameters of gait, and the Sonostar Double Head Wireless Mini Ultrasound device (Sonostar Inc., China) will be used to assess the thickness of the plantar fascia and Achilles tendons.
- Keywords
- Achilles tendon thickness, Plantar fascia thickness, Spatio-temporal parameteres of gait
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar fascia thickness
One of the researcher measured the thickness of the plantar fascia using Clarius L7 linear ultrasound. To image the plantar fascia, we positioned the patient in the prone position with the feet hanging off the table and the subtalar joint stabilized in the neutral position. Here, we placed the ultrasound probe on the line between the medial condyle of the calcaneus and the 2nd and 3rd toes and clearly showed the calcaneus.
Measured: Day 1
Achilless tendon thickness
One of the researcher measured the thickness of the Achilles tendon using Clarius L7 linear ultrasound. To image the Achilles tendon, we positioned the patient in the prone position with the feet hanging off the table and the subtalar joint stabilized in the neutral position. We measured the thickness of the tendon both longitudinally and transversely from the projection of the medial malleolus to the posterior aspect. We applied plenty and sufficient amount of gel to minimize the pressure and increase the contact and took 3 repeated images. We made an effort to minimize the pressure as much as possible during image acquisition.
Measured: Day 1
Spatio-temporal parameters of gait
The OptoGait Photoelectric Cell System (Microgate, Bolzano, BZ, Italy) was used to set up for collecting spatiotemporal parameters of gait and was calibrated by the manufacturer. The system was linked via an interface unit to a computer and the OptoGait software program (Microgate, Bolzano, Italy) used. The following spatiotemporal parameter of gait were extracted: step length (cm), stance phase (percent of gait cycle [%GC]), swing phase (%GC), single support (%GC), loading response (%GC), preswing (%GC), and step time (s), stride length (cm), double support (%GC), stride time (sec), cadence (steps/min), and gait speed (m/sec).
For familiarization of participants to treadmill, 6-minute trial-session used based on the study of Meyer et al (Meyer et al., 2019). For the test protocol; participants were asked to walk at self-selected walking pace for 1 minute on barefoot.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start30 Aug 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion5 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon ThicknessStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kısacık, PhD, Hacettepe University
- Investigators
- Pınar Kısacık, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976542
- Sponsor's protocol ID
- GO 23/442
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Plantar Fascia and Achilles Tendon Thickness Asymmetry and Spatio-temporal Parameters of Gait in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05976542
- Acronym / sponsor ID
- GO 23/442
- Keywords
- Achilles tendon thickness, Plantar fascia thickness, Spatio-temporal parameteres of gait
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 5 Oct 2023 (estimated)
- First posted
- 4 Aug 2023 (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.
There are studies on loading the foot with an increase in the thickness of the Plantar Fascia and Achilles Tendon.
However, no study was found that evaluated the relationship between morphological features such as plantar fascia and Achilles tendon thickness and spatio-temporal parameters of gait in healthy individuals.
In this study, it is aimed to investigate the relationship between the asymmetry in the thickness of the plantar fascia and Achilles tendon and the asymmetry in the spati-temporal parameters of gait.
Healthy adult volunteers aged 20-40 will participate in the research. Demographic data of the participants will be recorded in the study. Following this, a clinical evaluation of the foot and ankle will be made. The Optogait Photoelectric Cell System (Microgate, Bolzano, Italy) device will be used to record the spatio-temporal parameters of gait, and the Sonostar Double Head Wireless Mini Ultrasound device (Sonostar Inc., China) will be used to assess the thickness of the plantar fascia and Achilles tendons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult volunteers aged 20-40 will participate in the research.
Key inclusion criteria (5 listed)
- Being physically healthy (No symptoms or complaints at the moment, and no disease or trauma affecting the musculoskeletal system in the last 6 months)
- Being 20-40 years old
- Body Mass Index (BMI) being within the limits accepted as normal (18.5-24.9kg/m2) according to the World Health Organization (WHO)
- Classification of foot type as normal (API score= 0 to +5) as a result of the evaluation made with the Foot Posture Index (API) (38)
- Not having done any compelling (jogging, walking, weight or resistance training, yoga, pilates, aerobics, collective exercise sessions such as stepping…) exercises and activities in the last 2 days before the evaluation.
Key exclusion criteria (7 listed)
- Disease or problems that may affect walking (plantar fasciitis, having to use walking aids, visual or hearing impairment, other problems related to the lower extremities or spine)
- Having undergone orthopedic trauma or surgery involving the lower extremity
- Having symptoms of severe shortness of breath or intolerance of walking while walking
- Person; have a medical history that may indicate an increased risk of falling, such as fainting of unknown cause, blood sugar imbalance, unstable low or high blood pressure
- Congenital (pes planus, pes cavus, pes equinovarus, vertical talus, etc.) or acquired (pes planus and planovalgus, pes cavus, other deformities associated with foot arches…) foot deformity defined by clinical evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plantar fascia thickness
Time frame: Day 1
One of the researcher measured the thickness of the plantar fascia using Clarius L7 linear ultrasound. To image the plantar fascia, we positioned the patient in the prone position with the feet hanging off the table and the subtalar joint stabilized in the neutral position. Here, we placed the ultrasound probe on the line between the medial condyle of the calcaneus and the 2nd and 3rd toes and clearly showed the calcaneus.
Achilless tendon thickness
Time frame: Day 1
One of the researcher measured the thickness of the Achilles tendon using Clarius L7 linear ultrasound. To image the Achilles tendon, we positioned the patient in the prone position with the feet hanging off the table and the subtalar joint stabilized in the neutral position. We measured the thickness of the tendon both longitudinally and transversely from the projection of the medial malleolus to the posterior aspect. We applied plenty and sufficient amount of gel to minimize the pressure and increase the contact and took 3 repeated images. We made an effort to minimize the pressure as much as possible during image acquisition.
Spatio-temporal parameters of gait
Time frame: Day 1
The OptoGait Photoelectric Cell System (Microgate, Bolzano, BZ, Italy) was used to set up for collecting spatiotemporal parameters of gait and was calibrated by the manufacturer. The system was linked via an interface unit to a computer and the OptoGait software program (Microgate, Bolzano, Italy) used. The following spatiotemporal parameter of gait were extracted: step length (cm), stance phase (percent of gait cycle [%GC]), swing phase (%GC), single support (%GC), loading response (%GC), preswing (%GC), and step time (s), stride length (cm), double support (%GC), stride time (sec), cadence (steps/min), and gait speed (m/sec). For familiarization of participants to treadmill, 6-minute trial-session used based on the study of Meyer et al (Meyer et al., 2019). For the test protocol; participants were asked to walk at self-selected walking pace for 1 minute on barefoot.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Achilles Tendon Thickness
Active, not recruitingObservational study
Ultrasonographic Measurements of the Achilles Tendon and Talar Condylar Cartilage Thickness in Paraplegia Patients.
Paraplegia
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.
Pınar Kısacık principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendon Thickness and Plantar Fascia Thickness, run by Hacettepe University.
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 5 inclusion and 7 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 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Pınar Kısacık (+903123051576, pinar.dizmek@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plantar fascia thickness (time frame: Day 1). 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 15 Aug 2023.