Hallux Valgus Manual Therapy Based on Global Postural Reeducation. (HVMT)

July 10, 2020 updated by: DAVID CRUZ DÍAZ, University of Jaen

Effects of Global Postural Reeducation on Hallux Valgus

Manual approach of Hallux Valgus with global postural reeducation.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Hallux Abducto Valgus is a frequent pathology with a prevalence of 30% in women and 13% in men. The tendency is to increase with age.

Usually, the elected treatment is surgery, as the conservative orthopedic methods are used at the early stages of the pathology. Global Postural Re-Education is a manual therapy treatment method through which we can treat lots of pathologies. Some investigations demonstrate Postural Re-Education is effective for the treatment of temporomandibular disorders, urinary incontinence, and spine disorders, but there is no scientific evidence that defends the improvement of the symptoms and correction of the angle of the Hallux Abducto Valgus using Postural Re-Education.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • 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 Locations

      • Jaen, Spain, 23071
        • University of Jaén

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hallux abducto valgus with an angle between 15 - 39º
  • pain on the medial or plantar face of the forefoot
  • Physical independence to take part in the study.

Exclusion Criteria:

  • Being under hallux abducto valgus treatment.
  • Lower limb surgery.
  • Fracture or disfunction on the lower limb other than hallux valgus which may affect the studied variables.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients allocated to the control group did not receive any treatment.
Experimental: Global postural reeducation
Patients completed 3 sessions of global postural reeducation for 3 weeks.
It consisted of Global Postural Re-Education sessions divided into 3 sessions and performed with a frequency of 1 per week for 3 weeks. The sessions were performed individually, with an approximate duration of 40 minutes and all of them were assessed by the same physiotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural control
Time Frame: From baseline to 3 weeks and 8 weeks.
Postural control was evaluated by means of a stabilometric platform of resistive pressure sensors (Sensor Medica, Rome, Italy). There will be performed two tests: open eyes Romberg and closed eyes Romberg.
From baseline to 3 weeks and 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic balance
Time Frame: From baseline to 3 weeks and 8 weeks.
Dynamic balance has been measured by a simplified version of the Star Excursion Balance Test where the anterior, posteromedial and posterolateral reach directions were collected for statistical analysis.
From baseline to 3 weeks and 8 weeks.
Ankle range of motion
Time Frame: From baseline to 3 weeks and 8 weeks.
Ankle dorsiflexion range of motion was assessed by the weight-bearing lunge test. The patient is positioned in a standing position facing a wall with the involved foot parallel with a tape measure which has been attached to the floor and the opposite leg placed behind in a tandem stance. A forward lunge is performed until the anterior knee tries to make contact with the wall with the heel firmly planted on the ground.
From baseline to 3 weeks and 8 weeks.
Self-reported instability
Time Frame: From baseline to 3 weeks and 8 weeks.
To determine the severity of ankle instability the Cumberland ankle instability tool was used. The total score of the nine items ranges from 0 (severe instability) to 30 (normal stability).
From baseline to 3 weeks and 8 weeks.
Assessment of the grade of hallux valgus
Time Frame: From baseline to 3 weeks and 8 weeks.
With the Manchester Scale the examiners grade the feet of the participants in: A: no hallux valgus; B: mild hallux valgus; C: moderate hallux valgus; D: severe hallux valgus.
From baseline to 3 weeks and 8 weeks.
Foot posture
Time Frame: From baseline to 3 weeks and 8 weeks.
it will be performed the Foot Posture Index 6-items for evaluating the general foot position. It is graded as pronated, neutral or supinated depending on the punctuation
From baseline to 3 weeks and 8 weeks.
Passive and active dorsiflexion range of motion of the 1st metatarsophalangeal joint
Time Frame: From baseline to 3 weeks and 8 weeks.
it will be assessed by the Jack test, in which the phalangeal bone is passively dorsiflexed and the plantar arch is observed. The aim is classified the Windlass Mechanism in: intact; limited; absent. The active range of motion will be assessed by kinovea software.
From baseline to 3 weeks and 8 weeks.
Gait parameters
Time Frame: From baseline to 3 weeks and 8 weeks.
Gait parameters after treatment with optogait system including gait cycle, contact time, flight time, and pre-swing phase during walking and running.
From baseline to 3 weeks and 8 weeks.
Functional status
Time Frame: From baseline to 3 weeks and 8 weeks.
Function in daily living and sport activities were assessed by the Foot and Ankle Ability Measure. This questionnaire Is divided by two subscales of 21 items (daily living subscale) and 8 items (sports subscale). The obtained score is expressed as a percentage calculated by dividing the patient's score by max score and the lower percentage is related to the lower level of function.
From baseline to 3 weeks and 8 weeks.

Collaborators and Investigators

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

Investigators

  • Study Director: David Cruz-Diaz, PhD, University of Jaén

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)

September 1, 2019

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

February 26, 2020

Study Registration Dates

First Submitted

July 4, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Actual)

July 13, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

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.

Clinical Trials on Foot Deformities

Clinical Trials on Global postural reeducation

3
Subscribe