- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04468555
Hallux Valgus Manual Therapy Based on Global Postural Reeducation. (HVMT)
Effects of Global Postural Reeducation on Hallux Valgus
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jaen, Spain, 23071
- University of Jaén
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Experimental: Global postural reeducation
Patients completed 3 sessions of global postural reeducation for 3 weeks.
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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.
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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.
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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.
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From baseline to 3 weeks and 8 weeks.
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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.
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From baseline to 3 weeks and 8 weeks.
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Ankle range of motion
Time Frame: From baseline to 3 weeks and 8 weeks.
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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.
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From baseline to 3 weeks and 8 weeks.
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Self-reported instability
Time Frame: From baseline to 3 weeks and 8 weeks.
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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).
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From baseline to 3 weeks and 8 weeks.
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Assessment of the grade of hallux valgus
Time Frame: From baseline to 3 weeks and 8 weeks.
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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.
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From baseline to 3 weeks and 8 weeks.
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Foot posture
Time Frame: From baseline to 3 weeks and 8 weeks.
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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
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From baseline to 3 weeks and 8 weeks.
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Passive and active dorsiflexion range of motion of the 1st metatarsophalangeal joint
Time Frame: From baseline to 3 weeks and 8 weeks.
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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.
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From baseline to 3 weeks and 8 weeks.
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Gait parameters
Time Frame: From baseline to 3 weeks and 8 weeks.
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Gait parameters after treatment with optogait system including gait cycle, contact time, flight time, and pre-swing phase during walking and running.
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From baseline to 3 weeks and 8 weeks.
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Functional status
Time Frame: From baseline to 3 weeks and 8 weeks.
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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.
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From baseline to 3 weeks and 8 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: David Cruz-Diaz, PhD, University of Jaén
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HVUJA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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