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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04468555
Other study ID # HVUJA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date February 26, 2020

Study information

Verified date July 2020
Source University of Jaén
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Manual approach of Hallux Valgus with global postural reeducation.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date February 26, 2020
Est. primary completion date February 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Global 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.

Locations

Country Name City State
Spain University of Jaen Jaen

Sponsors (1)

Lead Sponsor Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From baseline to 3 weeks and 8 weeks.
Secondary 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. From baseline to 3 weeks and 8 weeks.
Secondary 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. From baseline to 3 weeks and 8 weeks.
Secondary 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). From baseline to 3 weeks and 8 weeks.
Secondary 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. From baseline to 3 weeks and 8 weeks.
Secondary 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 From baseline to 3 weeks and 8 weeks.
Secondary 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. From baseline to 3 weeks and 8 weeks.
Secondary Gait parameters 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.
Secondary 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. From baseline to 3 weeks and 8 weeks.
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