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

Primary Purpose

Hallux Valgus, Hallux Deformity, Foot Deformities

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Global postural reeducation
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Jaen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Global postural reeducation

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 4, 2020
Last Updated
July 10, 2020
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT04468555
Brief Title
Hallux Valgus Manual Therapy Based on Global Postural Reeducation.
Acronym
HVMT
Official Title
Effects of Global Postural Reeducation on Hallux Valgus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Manual approach of Hallux Valgus with global postural reeducation.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Hallux Deformity, Foot Deformities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A single-blind randomized controlled trial.
Masking
InvestigatorOutcomes Assessor
Masking Description
An independent assessor blinded to the data collection was responsible for the allocation process. A list of the computer-generated number was employed to assign participants to experimental or control group
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Global postural reeducation
Arm Type
Experimental
Arm Description
Patients completed 3 sessions of global postural reeducation for 3 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients allocated to the control group did not receive any treatment.
Intervention Type
Other
Intervention Name(s)
Global postural reeducation
Intervention Description
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 Outcome Measure Information:
Title
Postural control
Description
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 Outcome Measure Information:
Title
Dynamic balance
Description
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.
Title
Ankle range of motion
Description
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.
Title
Self-reported instability
Description
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.
Title
Assessment of the grade of hallux valgus
Description
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.
Title
Foot posture
Description
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.
Title
Passive and active dorsiflexion range of motion of the 1st metatarsophalangeal joint
Description
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.
Title
Gait parameters
Description
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.
Title
Functional status
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cruz-Diaz, PhD
Organizational Affiliation
University of Jaén
Official's Role
Study Director
Facility Information:
Facility Name
University of Jaen
City
Jaen
ZIP/Postal Code
23071
Country
Spain

12. IPD Sharing Statement

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Hallux Valgus Manual Therapy Based on Global Postural Reeducation.

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