Effect of Postural Insoles on Stability and Leg Muscular Activity

Effect of Postural Metatarsal Bar Orthotic Element on Stability and Leg Muscular Activity. A Randomized Clinical Trial

Posturology allows to treat postural problems by using postural insoles, which will have an effect at the neurophysiological level. Pieces of 1 to 3 millimeters are inserted to stimulate specific receptors located on the sole of the foot, which will affect the muscular proprioception and modify the activation of the ascending muscle chains.

The hypothesis of this work is based on the fact that the use of postural insoles with a 2 millimeters metatarsal bar will influence the displacement of the center of pressure and the muscle activity of the leg when compared with a placebo insoles.

Participants will be healthy subjects and will be divided into two groups, control and experimental. Subjects in the control group will be given a pair of flat insoles (placebo insoles) with 1.2 millimeters polyester resin. Those of the experimental group will be made the same insoles but they will include by thermal fusion a metatarsal bar of 2 millimeters polyester resin in the metatarsal zone corresponding to the 1st, 2nd, 3rd and 4th metatarsal head.

Postural stability analysis will be performed with the force platform of the Biomechanics Institute of Valencia (IBV-Spain) and at the same time an electromyographic analysis in the dominant leg with a surface electromyograph system. Subjects will be assessed with their eyes open and closed under two situations, with footwear and with footwear and insoles.

Study Overview

• Status: Completed
• Conditions: Postural Stability; Muscular Activity
• Intervention / Treatment: Diagnostic test: Postural stability assessment with a force platform.; Diagnostic test: Muscular assessment with a electromyograph

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cáceres
    • Plasencia, Cáceres, Spain, 10600
      • Alfonso Martínez Nova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects with no discomfort in gait
• Subjects with not muscle and skeletal diseases

Exclusion Criteria:

• Subjects with balance disorders, pain at legs
• Subjects with loss of balance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Flat Insole (no metatarsal bar); Postural stability and electromyographic activity in the dominant leg will be assessed with the subject shod (closed clog) and with 1.2 millimeters flat polyester resin insoles.	Diagnostic test: Postural stability assessment with a force platform.; The postural stability will be assessed in static by means of the antero-posterior and medio-lateral displacements of the center of pressure in Romberg open and closed eyes test measured with a force platform (NED/SVE-IBV-Spain). Three 30-second measurements will be made in each condition.; Diagnostic test: Muscular assessment with a electromyograph; The activity of the medial and lateral gastrocnemius, soleus and anterior tibial muscles of the dominant leg will be assessed with the mDurance surface electromiograph at the same time as postural stability analysis is performed.Three 30-second measurements will be made in each condition.
Experimental: Flat Insole (with 2 millimeters metatarsal bar); Postural stability and electromyographic activity in the dominant leg will be assessed with the subject shod (closed clog) and with 1.2 millimeters flat polyester resin insoles with a 2 millimeters polyester resin metatarsal bar.	Diagnostic test: Postural stability assessment with a force platform.; The postural stability will be assessed in static by means of the antero-posterior and medio-lateral displacements of the center of pressure in Romberg open and closed eyes test measured with a force platform (NED/SVE-IBV-Spain). Three 30-second measurements will be made in each condition.; Diagnostic test: Muscular assessment with a electromyograph; The activity of the medial and lateral gastrocnemius, soleus and anterior tibial muscles of the dominant leg will be assessed with the mDurance surface electromiograph at the same time as postural stability analysis is performed.Three 30-second measurements will be made in each condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of postural balance	The mediolateral and anteroposterior excursion of centre of pressures will be measured in millimeters with a force platform with and without the insoles	From baseline to 10 minutes
Change of muscular activity	The muscular activity in gastrocnemius, soleus and tibialis anterioris will be measured as a percentage (%) with a surface electromyograph in one leg with and without the insoles	From baseline to 10 minutes

Collaborators and Investigators

• Sponsor: Universidad de Extremadura

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): April 22, 2021

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Insoles; Postural stability; Metatarsal Bar; Electromyograph Activity
• Other Study ID Numbers: FOSSIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No