Hallux ValgusHVMTNCT04468555
Hallux Valgus Manual Therapy Based on Global Postural Reeducation.
A study testing Global postural reeducation in people with Hallux Valgus and Hallux Deformity, run by University of Jaén at 1 site in Spain.
Trial summary
Manual approach of Hallux Valgus with global postural reeducation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hallux Valgus, Hallux Deformity, Foot Deformities
- What is being tested?
- Global postural reeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to 26 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Global Postural Reeducation on Hallux Valgus
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.
- Conditions
- Hallux Valgus, Hallux Deformity, Foot Deformities
- Being tested
- Global postural reeducation
- Medical subject headings
- Hallux Valgus, Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global postural reeducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Global postural reeducation | Experimental | Patients completed 3 sessions of global postural reeducation for 3 weeks. Receives: Other: Global postural reeducation |
| Control group | No intervention | Patients allocated to the control group did not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 3 weeks and 8 weeks.
Secondary outcomes (8)
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.
Measured: From baseline to 3 weeks and 8 weeks.
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.
Measured: From baseline to 3 weeks and 8 weeks.
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).
Measured: From baseline to 3 weeks and 8 weeks.
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.
Measured: From baseline to 3 weeks and 8 weeks.
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
Measured: From baseline to 3 weeks and 8 weeks.
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.
Measured: From baseline to 3 weeks and 8 weeks.
Gait parameters
Gait parameters after treatment with optogait system including gait cycle, contact time, flight time, and pre-swing phase during walking and running.
Measured: From baseline to 3 weeks and 8 weeks.
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.
Measured: From baseline to 3 weeks and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Sep 2019
- Primary completion20 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAVID CRUZ DÍAZ, University of Jaén
- Investigators
- David Cruz-Diaz, PhD, Study director, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468555
- Sponsor's protocol ID
- HVUJA
- Acronym
- HVMT
- Status last verified
- Jul 2020
- First submitted
- 4 Jul 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Global Postural Reeducation on Hallux Valgus
- ClinicalTrials.gov ID
- NCT04468555
- Acronym / sponsor ID
- HVMT / HVUJA
- Conditions
- Hallux Valgus, Hallux Deformity, Foot Deformities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A single-blind randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Global postural reeducation | Experimental | Other: Global postural reeducationPatients completed 3 sessions of global postural reeducation for 3 weeks. |
| Control group | No intervention | –Patients allocated to the control group did not receive any treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global postural reeducationIt 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. | Other | Global postural reeducation |
Primary outcome
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.
8 secondary outcomes
Dynamic balance
Time frame: From baseline to 3 weeks and 8 weeks.
Ankle range of motion
Time frame: From baseline to 3 weeks and 8 weeks.
Self-reported instability
Time frame: From baseline to 3 weeks and 8 weeks.
Assessment of the grade of hallux valgus
Time frame: From baseline to 3 weeks and 8 weeks.
Foot posture
Time frame: From baseline to 3 weeks and 8 weeks.
Passive and active dorsiflexion range of motion of the 1st metatarsophalangeal joint
Time frame: From baseline to 3 weeks and 8 weeks.
Gait parameters
Time frame: From baseline to 3 weeks and 8 weeks.
Functional status
Time frame: From baseline to 3 weeks and 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Cruz-Diaz, PhD study director
University of Jaén
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global postural reeducation in people with Hallux Valgus and Hallux Deformity, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural control (time frame: From baseline to 3 weeks and 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.