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Completed

NCT Number: NCT04468555

Hallux Valgus Manual Therapy Based on Global Postural Reeducation.

Manual approach of Hallux Valgus with global postural reeducation.

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Key information

Conditions

Hallux Valgus Foot Deformities Hallux Deformity Musculoskeletal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Jaen

Jaén, 23071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Global postural reeducation

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study title

Effects of Global Postural Reeducation on Hallux Valgus

Acronym: HVMT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 13, 2020
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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