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The Effects of Short-foot Exercises in Foot Posture

Primary Purpose

Pronation Deformity of the Foot

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Short foot excercise for intrinsec muscles of the foot
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pronation Deformity of the Foot focused on measuring pronation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Males and females between 18 and 65 years old.

-

Exclusion Criteria:

  • The exclusion criteria: serious illness, current participation in another research study, pregnancy, previous foot surgery, current treatment of foot pathology.

Sites / Locations

  • Aurora Castro Mendez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

experimental

Control

Arm Description

The short foot exercise daily for 4 weeks

A placebo excercise daily for 4 weeks

Outcomes

Primary Outcome Measures

Foot posture index
the foot posture will be evaluated with the foot posture index (FPI) .The foot posture index is a validated and useful method like a complementary tool for evaluating foot disorders. 5. The foot posture quantify the foot posture as normal, pronated or supinated. A podiatrist assessed the foot posture during the biomechanical assessment based on the six-item foot posture index (FPI≥+6). The FPI consists of six validated items measured in a standing relaxed position of the subject; The categories are: Supinated foot: -1 a -12. Neutral foot posture: 0 to +5 (neutral). Pronated foot posture: +6 to +12.

Secondary Outcome Measures

Full Information

First Posted
June 13, 2019
Last Updated
October 23, 2019
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT03993470
Brief Title
The Effects of Short-foot Exercises in Foot Posture
Official Title
The Effects of Short-foot Exercises in the Foot Posture
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

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

5. Study Description

Brief Summary
Therefore, the aim of this study is to examine the effects of the short foot exercises compared to placebo exercises in the foot posture index after a daily period of 4 weeks.
Detailed Description
The intrinsic foot muscles collaborate in maintain the media longitudinal arch and in the postural control of the body.1 The plantar intrinsic foot muscles play a crucial role providing the foot stability and flexibility. 2 There are few studies about the relationship between hyperpronation and the training of the intrinsic muscles. A specific training program as a "short foot exercise" (SFE) may improve pathological conditions involving the foot and the lower extremity including plantar fasciitis, tendinopathies and foot hiperpronation.3 Several balance training techniques have been applied for improving postural stability, and the SFE have been widely accepted by physiotherapists to improve the longitudinal arch foot and the body segments.4 In this study, the foot posture will be evaluated with the foot posture index (FPI) and the navicular drop test (NDT). The foot posture index is a validated and useful method like a complementary tool for evaluating foot disorders. 5. The foot posture quantify the foot posture as normal, pronated or supinated. The foot posture index indicates a pronated foot position in a support relaxed position when IPP is equal to or superior to a +6 value. 5 The Navicular Drop Test quantifies, in millimeters, the descent of the navicular tuberosity. It was developed to evaluate the pronation of the foot and, consequently, the drop of the medial longitudinal arch, a excessively pronated foot (NDT≥10mm).6. Therefore, the aim of this study is to examine the effects of the SFE compared to a placebo exercise in the foot posture index after a daily period of 4 weeks. There is a lack of evidence of the effect of training intrinsic muscles in foot posture. The hypothesis of the researches is that the SFE may contribute to improving the pronated foot posture. This treatment may allow normalizing the foot posture and the kinematic interaction of the lower extremity joints during walking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pronation Deformity of the Foot
Keywords
pronation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Blind
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
The short foot exercise daily for 4 weeks
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
A placebo excercise daily for 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
Short foot excercise for intrinsec muscles of the foot
Intervention Description
to examine the effects of the SFE compared to a placebo exercise in the foot posture index after a daily period of 4 weeks.
Primary Outcome Measure Information:
Title
Foot posture index
Description
the foot posture will be evaluated with the foot posture index (FPI) .The foot posture index is a validated and useful method like a complementary tool for evaluating foot disorders. 5. The foot posture quantify the foot posture as normal, pronated or supinated. A podiatrist assessed the foot posture during the biomechanical assessment based on the six-item foot posture index (FPI≥+6). The FPI consists of six validated items measured in a standing relaxed position of the subject; The categories are: Supinated foot: -1 a -12. Neutral foot posture: 0 to +5 (neutral). Pronated foot posture: +6 to +12.
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females between 18 and 65 years old. - Exclusion Criteria: The exclusion criteria: serious illness, current participation in another research study, pregnancy, previous foot surgery, current treatment of foot pathology.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
aurora c castro mendez
Organizational Affiliation
Departament of Podiatry. University of Seville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora Castro Mendez
City
Sevilla
ZIP/Postal Code
41018
Country
Spain

12. IPD Sharing Statement

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The Effects of Short-foot Exercises in Foot Posture

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