Pronation Deformity of the FootNCT03993470
The Effects of Short-foot Exercises in Foot Posture
A study testing Short foot excercise for intrinsec muscles of the foot in people with Pronation Deformity of the Foot, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pronation Deformity of the Foot
- What is being tested?
- Short foot excercise for intrinsec muscles of the foot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jul 2019to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females between 18 and 65 years old.
- -
Who cannot join
- The exclusion criteria: serious illness, current participation in another research study, pregnancy, previous foot surgery, current treatment of foot pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Short-foot Exercises in the Foot Posture
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.
Read the 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.
- Conditions
- Pronation Deformity of the Foot
- Being tested
- Short foot excercise for intrinsec muscles of the foot
- Keywords
- pronation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short foot excercise for intrinsec muscles of the footBehavioural
to examine the effects of the SFE compared to a placebo exercise in the foot posture index after a daily period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | The short foot exercise daily for 4 weeks Receives: Behavioral: Short foot excercise for intrinsec muscles of the foot |
| Control | Placebo comparator | A placebo excercise daily for 4 weeks Receives: Behavioral: Short foot excercise for intrinsec muscles of the foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start3 Jul 2019
- Primary completion1 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pronation Deformity of the FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurora Castro Mendez, University of Seville
- Investigators
- aurora c castro mendez, Principal investigator, Departament of Podiatry. University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993470
- Sponsor's protocol ID
- 0465
- Status last verified
- Oct 2019
- First submitted
- 13 Jun 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Short-foot Exercises in the Foot Posture
- ClinicalTrials.gov ID
- NCT03993470
- Acronym / sponsor ID
- 0465
- Conditions
- Pronation Deformity of the Foot
- Keywords
- pronation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: Short foot excercise for intrinsec muscles of the footThe short foot exercise daily for 4 weeks |
| Control | Placebo comparator | Behavioral: Short foot excercise for intrinsec muscles of the footA placebo excercise daily for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females between 18 and 65 years old.
- -
Key exclusion criteria (1 listed)
- The exclusion criteria: serious illness, current participation in another research study, pregnancy, previous foot surgery, current treatment of foot pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short foot excercise for intrinsec muscles of the footto examine the effects of the SFE compared to a placebo exercise in the foot posture index after a daily period of 4 weeks. | Behavioural | Control, experimental |
Primary outcome
Foot posture index
Time frame: four weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
aurora c castro mendez principal investigator
Departament of Podiatry. University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short foot excercise for intrinsec muscles of the foot in people with Pronation Deformity of the Foot, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot posture index (time frame: four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.