Effect of Postural Insoles on Stability and Leg Muscular Activity

NCT04836650 | Completed DMC

• 1 other identifier: FOSSIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postural Stability; Muscular Activity

Keywords

Metatarsal Bar; Insoles; Postural stability; Electromyograph Activity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Flat Insole (no metatarsal bar)

PLACEBO COMPARATOR

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.; Diagnostic Test: Muscular assessment with a electromyograph

Flat Insole (with 2 millimeters metatarsal bar)

EXPERIMENTAL

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.; Diagnostic Test: Muscular assessment with a electromyograph

Interventions

Postural stability assessment with a force platform. DIAGNOSTIC_TEST

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.

Flat Insole (no metatarsal bar); Flat Insole (with 2 millimeters metatarsal bar)

Muscular assessment with a electromyograph DIAGNOSTIC_TEST

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.

Flat Insole (no metatarsal bar); Flat Insole (with 2 millimeters metatarsal bar)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Extremadura: lead

Study Sites (1)

Alfonso Martínez Nova

Plasencia, Cáceres, 10600, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: April 8, 2021
• Study Start: April 6, 2021
• Primary Completion: April 15, 2021
• Study Completion: April 22, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)