NCT03993470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

July 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

June 13, 2019

Last Update Submit

October 23, 2019

Conditions

Pronation Deformity of the Foot

Keywords

pronation

Outcome Measures

Primary Outcomes (1)

  • 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.

    four weeks

Study Arms (2)

experimental

EXPERIMENTAL

The short foot exercise daily for 4 weeks

Behavioral: Short foot excercise for intrinsec muscles of the foot

Control

PLACEBO COMPARATOR

A placebo excercise daily for 4 weeks

Behavioral: Short foot excercise for intrinsec muscles of the foot

Interventions

Short foot excercise for intrinsec muscles of the footBEHAVIORAL

to examine the effects of the SFE compared to a placebo exercise in the foot posture index after a daily period of 4 weeks.

Controlexperimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females between 18 and 65 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aurora Castro Mendez

Seville, 41018, Spain

Location

Study Officials

  • aurora c castro mendez

    Departament of Podiatry. University of Seville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Blind
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 20, 2019

Study Start

July 3, 2019

Primary Completion

October 1, 2019

Study Completion

October 15, 2019

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations

ES(1)