CClinicalTrials.gg
CompletedNCT04468555HVMTUpdated Jul 13, 2020

Hallux Valgus Manual Therapy Based on Global Postural Reeducation.

An interventional study of Global postural reeducation in Hallux Valgus, Hallux Deformity and Foot Deformities, sponsored by University of Jaén. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-13.

Sponsored by University of Jaén · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Manual approach of Hallux Valgus with global postural reeducation.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Global postural reeducation

    Patients completed 3 sessions of global postural reeducation for 3 weeks.

    Other: Global postural reeducation

  • No intervention
    Control group

    Patients allocated to the control group did not receive any treatment.

Interventions

  • OtherGlobal postural reeducation

    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.

05

What researchers measure

Primary outcomes

  1. Postural control

    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.

    Time frame: From baseline to 3 weeks and 8 weeks.

Secondary outcomes

  1. Dynamic balance

    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.

    Time frame: From baseline to 3 weeks and 8 weeks.

  2. Ankle range of motion

    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.

    Time frame: From baseline to 3 weeks and 8 weeks.

  3. Self-reported instability

    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).

    Time frame: From baseline to 3 weeks and 8 weeks.

  4. Assessment of the grade of hallux valgus

    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.

    Time frame: From baseline to 3 weeks and 8 weeks.

  5. Foot posture

    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

    Time frame: From baseline to 3 weeks and 8 weeks.

  6. Passive and active dorsiflexion range of motion of the 1st metatarsophalangeal joint

    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.

    Time frame: From baseline to 3 weeks and 8 weeks.

  7. Gait parameters

    Gait parameters after treatment with optogait system including gait cycle, contact time, flight time, and pre-swing phase during walking and running.

    Time frame: From baseline to 3 weeks and 8 weeks.

  8. Functional status

    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.

    Time frame: From baseline to 3 weeks and 8 weeks.

06

Study locations

1 site
  • University of Jaen
    Jaen, 23071, Spain
07

Registry details

Key details

Study ID
NCT04468555
Lead sponsor
University of Jaén
Responsible party
DAVID CRUZ DÍAZ (Professor, University of Jaén) — Principal investigator
First posted
Jul 13, 2020
Start date
Sep 1, 2019
Primary completion
Feb 20, 2020
Completion
Feb 26, 2020
Last update
Jul 13, 2020

Study contacts

David Cruz-Diaz, PhD
study director · University of Jaén

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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