Effect of Postural Insoles on Stability and Leg Muscular Activity

Sponsor

Universidad de Extremadura (Other)

Overall Status

Completed

CT.gov ID

NCT04836650

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

76.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postural Stability Muscular Activity	Diagnostic Test: Postural stability assessment with a force platform. Diagnostic Test: Muscular assessment with a electromyograph	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 6, 2021

Actual Primary Completion Date :

Apr 15, 2021

Actual Study Completion Date :

Apr 22, 2021

Arms and Interventions

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.

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.

Diagnostic Test: Muscular assessment with a electromyograph

Outcome Measures

Primary Outcome Measures

Change of postural balance [From baseline to 10 minutes]
The mediolateral and anteroposterior excursion of centre of pressures will be measured in millimeters with a force platform with and without the insoles
Change of muscular activity [From baseline to 10 minutes]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alfonso Martínez Nova	Plasencia	Cáceres	Spain	10600

Sponsors and Collaborators

Universidad de Extremadura

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alfonso Martínez Nova, Clinical Professor, Universidad de Extremadura

ClinicalTrials.gov Identifier:

NCT04836650

Other Study ID Numbers:

FOSSIL

First Posted:

Apr 8, 2021

Last Update Posted:

Apr 26, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alfonso Martínez Nova, Clinical Professor, Universidad de Extremadura

Metatarsal Bar

Insoles

Postural stability

Electromyograph Activity

Study Results

No Results Posted as of Apr 26, 2021