Influence of Gait and Running on Foot Posture
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05947591 |
|
Recruitment Status :
Recruiting
First Posted : July 17, 2023
Last Update Posted : July 19, 2023
|
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 28, 2023 | ||||||||
| First Posted Date | July 17, 2023 | ||||||||
| Last Update Posted Date | July 19, 2023 | ||||||||
| Actual Study Start Date | June 20, 2023 | ||||||||
| Actual Primary Completion Date | June 20, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Influence of Gait and Running on Foot Posture | ||||||||
| Official Title | Influence of Gait and Running on Foot Posture Index and Navicular Drop Modifications for Non-athletes. | ||||||||
| 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. |
||||||||
| 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 Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Healthy non atletes subjects | ||||||||
| Condition | Foot Pronation in Healthy Adult | ||||||||
| Intervention | 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
|
||||||||
| Study Groups/Cohorts |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
25 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | July 25, 2023 | ||||||||
| Actual Primary Completion Date | June 20, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility 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. - Exclusion Criteria: a congenital or traumatic foot deformity, wearing plantar supports, pregnancy or being in current rehabilitation treatment or serious illness. - |
||||||||
| Sex/Gender |
|
||||||||
| Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | Spain | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT05947591 | ||||||||
| Other Study ID Numbers | 0973-N-20 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement |
|
||||||||
| Current Responsible Party | Aurora Castro Mendez, University of Seville | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | University of Seville | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | University of Seville | ||||||||
| Verification Date | July 2023 | ||||||||