The Relationship Between Plantar Fascia and Achilles Tendon Thickness Asymmetry and Spatio-temporal Parameters of Gait

• ClinicalTrials.gov Identifier: NCT05976542
• Recruitment Status: Not yet recruiting
• First Posted: August 4, 2023
• Last Update Posted: August 15, 2023
• Sponsor: Hacettepe University
• Information provided by (Responsible Party): Pınar Kısacık, PhD, Hacettepe University

Tracking Information

• First Submitted Date: July 19, 2023
• First Posted Date: August 4, 2023
• Last Update Posted Date: August 15, 2023
• Estimated Study Start Date: August 30, 2023
• Estimated Primary Completion Date: September 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 27, 2023)

• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Relationship Between Plantar Fascia and Achilles Tendon Thickness Asymmetry and Spatio-temporal Parameters of Gait
• Official Title: Investigation of the Relationship Between Plantar Fascia and Achilles Tendon Thickness Asymmetry and Spatio-temporal Parameters of Gait in Healthy Individuals

Brief 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 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.

• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 1 Week
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Healthy adult volunteers aged 20-40 will participate in the research.

Condition

• Achilles Tendon Thickness
• Plantar Fascia Thickness
• Spatio-temporal Parameteres of Gait

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: July 27, 2023): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 5, 2023
• Estimated Primary Completion Date: September 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Pınar Kısacık; +903123051576; pinar.dizmek@hacettepe.edu.tr

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05976542
• Other Study ID Numbers: GO 23/442
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Pınar Kısacık, PhD, Hacettepe University
• Original Responsible Party: Same as current
• Current Study Sponsor: Hacettepe University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Pınar Kısacık; Hacettepe University

• PRS Account: Hacettepe University
• Verification Date: August 2023