Influence of Gait and Running on Foot Posture

• ClinicalTrials.gov Identifier: NCT05947591
• Recruitment Status: Recruiting
• First Posted: July 17, 2023
• Last Update Posted: July 19, 2023
• Sponsor: University of Seville
• Information provided by (Responsible Party): Aurora Castro Mendez, University of Seville

Study Description

Brief Summary:

Objective: To evaluate in a sample of healthy non-athlete subjects, if the foot tends to a pronated position during a period of running compared to walking, evaluated during and after one hour after performing said activity.

Design: Quasi-experimental study, experimental and control group. Setting: Subjects who attend the Podiatry Clinical Area of the University of Seville.

Participants: N=72 healthy non-athlete volunteer adults who regularly run.

Condition or disease	Intervention/treatment
Foot Pronation in Healthy Adult	Behavioral: foot posture index

Detailed Description:

Interventions: The volunteers will participate in the research on three occasions, the day of data collection, one day when they will carry out a one-hour walking period and on another occasion where they will carry out an hour of running. Changes in foot posture [FPI] or foot pronation position (navicular drop [ND]) were identified in various periods of time at the time of the initial assessment and examination (p1), after 30 minutes of walking or running ( p2), 45 minutes of walking or running (p3) and 60 minutes of walking or running (p4) of the activity elapsed.

Main outcome measures: Foot position will be measured using the Foot Posture Index (FPI) and navicular height using the navicular drop test (ND) at p1, p2, p3 and p4.

Study Design

• Study Type: Observational
• Estimated Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Influence of Gait and Running on Foot Posture Index and Navicular Drop Modifications for Non-athletes.
• Actual Study Start Date: June 20, 2023
• Actual Primary Completion Date: June 20, 2023
• Estimated Study Completion Date: July 25, 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
control; healthy adults than gait over 1 hour,	Behavioral: foot posture index; the tendency to foot pronation in healthy subjects will be compared during one hour of walking versus one hour of running in subjects who usually run.; Other Name: Navicular drop test
experimental; healthy adults that run over 1 hour	Behavioral: foot posture index; the tendency to foot pronation in healthy subjects will be compared during one hour of walking versus one hour of running in subjects who usually run.; Other Name: Navicular drop test

Outcome Measures

Primary Outcome Measures :

1. Foot posture index [ Time Frame: 15 minutes ]

   The FPI consists of 6 criteria obtained from the subject's foot where each of them gives a score from -2 to +12. Its use is simple and is scientifically validated.

   The subject must be in a comfortable standing position where they support their feet as they usually do naturally. Its realization lasts approximately 2 minutes maximum for each of the feet, and after its execution an independent total value is obtained for each one of them that indicates a pronated, supinated or normal posture that goes from -12 to +12 value. .

2. navicular drop test [ Time Frame: 15 minutes ]
   to evaluate the difference between the original height of the navicular tuberosity in sitting position and in load corresponds to the drop of the scaphoids, therefore, to the descent of the internal longitudinal arch

Secondary Outcome Measures :

1. Foot posture index [ Time Frame: 60 minutes ]

   The FPI consists of 6 criteria obtained from the subject's foot where each of them gives a score from -2 to +12. Its use is simple and is scientifically validated.

   The subject must be in a comfortable standing position where they support their feet as they usually do naturally. Its realization lasts approximately 2 minutes maximum for each of the feet, and after its execution an independent total value is obtained for each one of them that indicates a pronated, supinated or normal posture that goes from -12 to +12 value. .

2. Navicular drop test [ Time Frame: 60 minutes ]
   o evaluate the difference between the original height of the navicular tuberosity in sitting position and in load corresponds to the drop of the scaphoids, therefore, to the descent of the internal longitudinal arch

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Healthy non atletes subjects

Criteria

Inclusion Criteria:

The inclusion criteria are: healthy adults, of both sexes, who come to the center on the indicated date and who are professional athletes but who do practice some regular physical activity, understood as running for one hour three times a week as minimum.

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Exclusion Criteria:

a congenital or traumatic foot deformity, wearing plantar supports, pregnancy or being in current rehabilitation treatment or serious illness.

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Contacts and Locations

Contacts

Contact: Aurora Castro Mendez, PhD; +34954486526; auroracastro@us.es

Contact: Aurora Castro Mendez; +34 954486569; clinicapieydeporte@gmail.com

Locations

Spain

Aurora Castro Mendez; Recruiting

Sevilla, Spain, 41018

Contact: aurora c mendez 677608957

Sponsors and Collaborators

University of Seville

More Information

• Responsible Party: Aurora Castro Mendez, PhD, University of Seville
• ClinicalTrials.gov Identifier: NCT05947591
• Other Study ID Numbers: 0973-N-20
• First Posted: July 17, 2023
• Last Update Posted: July 19, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Aurora Castro Mendez, University of Seville:

run; pronation; adult; sport