NCT04468555

Brief Summary

Manual approach of Hallux Valgus with global postural reeducation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

July 4, 2020

Last Update Submit

July 10, 2020

Conditions

Outcome Measures

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.

    From baseline to 3 weeks and 8 weeks.

Secondary Outcomes (8)

  • Dynamic balance

    From baseline to 3 weeks and 8 weeks.

  • Ankle range of motion

    From baseline to 3 weeks and 8 weeks.

  • Self-reported instability

    From baseline to 3 weeks and 8 weeks.

  • Assessment of the grade of hallux valgus

    From baseline to 3 weeks and 8 weeks.

  • Foot posture

    From baseline to 3 weeks and 8 weeks.

  • +3 more secondary outcomes

Study Arms (2)

Global postural reeducation

EXPERIMENTAL

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

Other: Global postural reeducation

Control group

NO INTERVENTION

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

Interventions

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.

Global postural reeducation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jaen

Jaén, 23071, Spain

Location

MeSH Terms

Conditions

Hallux ValgusFoot Deformities

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • David Cruz-Diaz, PhD

    University of Jaén

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A single-blind randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 4, 2020

First Posted

July 13, 2020

Study Start

September 1, 2019

Primary Completion

February 20, 2020

Study Completion

February 26, 2020

Last Updated

July 13, 2020

Record last verified: 2020-07

Locations