Orthotic Impact on MTP Alignment in Hallux Valgus

April 27, 2026 updated by: CARMEN GARCÍA GOMARIZ, University of Valencia

Evaluation of Metatarsophalangeal Joint Alignment in Mild and Moderate Hallux Abducto Valgus Through Orthotic Intervention

This study aims to evaluate the effectiveness of an external corrector in realigning the first metatarsophalangeal joint in patients with mild to moderate Hallux Abducto Valgus, according to the Manchester scale. Changes in valgus angle will be assessed through radiographs, along with pain, comfort and adherence, comparing results with a control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction and Rationale Hallux Abducto Valgus (HAV) is the most common forefoot deformity, often associated with pain and functional limitations. Its development is multifactorial, and although surgical and conservative treatments exist, evidence regarding the real effectiveness of corrective orthopedic devices in early stages is scarce. This study seeks to provide scientific rigor to a device frequently recommended in clinical practice by evaluating its ability to correct alignment and improve symptoms.

Main and Secondary Objectives The primary objective is to assess the effectiveness of the corrector in realigning the first toe by measuring the valgus angle radiographically at three time points: without the corrector, immediately after application, and after 3 months. Secondary objectives include evaluating pain (VAS), comfort, adherence, device fit, changes in plantar pressure (static and dynamic), patient satisfaction, and differences compared to the control group.

Study Design and Population This is an experimental study involving a group of 35 subjects diagnosed with mild or moderate HAV according to the Manchester scale, recruited at the Aquilesia podiatry clinic (Vila-real, Castelló). Recruitment will be carried out through local media, social networks, and referrals from healthcare professionals. Informed consent, anonymity, and compliance with data protection regulations will be ensured.

Intervention and Measurements The intervention consists of applying an external hallux alignment corrector. Three radiographic measurements of the metatarsophalangeal angle will be taken: baseline, after corrector placement, and at 3 months. Additional data will include pain, comfort, adherence and device adjustment. Standardized scales (VAS, satisfaction questionnaires) and Excel-based data recording will be used.

Data Processing and Analysis Data will be collected by a podiatrist and anonymized before analysis. Intra- and intergroup differences will be evaluated using appropriate statistical tests, considering variables such as sex, age, and degree of deformity. The study aims to determine whether the corrector produces significant improvements in alignment and other clinical parameters, providing evidence for its usefulness in podiatric practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Carmen García Gomariz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Sex: Male or female Age: 18 to 80 years Cooperative subject, informed of the need and duration of follow-up visits, ensuring full compliance with the protocol/study, and having signed informed consent No previous surgery on the foot and/or ankle Mild and/or moderate Hallux Valgus (Manchester Scale)

Exclusion Criteria:

  • Patient with severe arteriopathy Patient with severe edema Patient with sensory neuropathy Patients who have used additional pharmacological treatments (analgesics/anti-inflammatories) during the entire study period Severe Hallux Valgus (Manchester Scale) Any systemic disease affecting the musculoskeletal system Rheumatoid arthritis involving the first metatarsophalangeal joint Instability of the first metatarsophalangeal joint History of previous foot and/or ankle surgery Hyperpronated foot with FPI >10 Severe pathological genu varum or valgum Pregnant women or suspected pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Orthosis
The study group will consist of 35 adult subjects, both men and women, diagnosed with mild to moderate Hallux Abducto Valgus (HAV) according to the Manchester scale.
Device: Hallux Valgus Orthosis
This study evaluates the effectiveness of an external hallux valgus orthosis in realigning the first metatarsophalangeal joint in patients with mild to moderate HAV. Two radiographic measurements of the valgus angle will be taken: at baseline and after 3 months of daily orthosis use. Participants will receive instructions for proper placement and adjustment. Secondary outcomes include pain (VAS), comfort, satisfaction, plantar pressure analysis (static/dynamic), device fit, and adherence. Data will be collected by podiatrists and anonymized for analysis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Radiographic Valgus Angle Correction
Time Frame: 3 months
Measurement of the hallux valgus angle on digital radiographs at baseline and after 3 months of orthosis use, to determine the degree of realignment of the first metatarsophalangeal joint.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device Fit and Adjustment
Time Frame: 1day
Evaluation of orthosis sizing and traction adjustment scored on a 1-10 scale, including ease of placement by the participant.
1day
Orthosis Condition After Use
Time Frame: 3 months
Assessment of wear and tear of the device after 3 months, scored on a 1-10 scale.
3 months
Adherence to Treatment
Time Frame: 3 months
Monitoring of daily orthosis use through self-reported logs and follow-up visits.
3 months
Purchase Decision
Time Frame: 3 months
Whether the participant would consider buying the orthosis after the study (Yes/No).
3 months
Pain Assessment (VAS)
Time Frame: 3 months
Evaluation of pain intensity in the hallux region using the Visual Analog Scale (0 = no pain, 10 = worst pain).
3 months
Comfort and Satisfaction
Time Frame: 3 months

Subjective assessment of comfort, aesthetics, and overall satisfaction with the orthosis through a structured questionnaire.

Comfort was evaluated using a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no comfort and 10 indicates maximum comfort.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: CARMEN GARCÍA GOMARIZ, UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EJC_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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