Effect of Postural Insoles on Stability and Leg Muscular Activity

Postural Stability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836650
• Other study ID #: FOSSIL
• Status: Completed
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: April 22, 2021

Study information

• Verified date: April 2021
• Source: Universidad de Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 22, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscular Activity
• Postural Stability

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Alfonso Martínez Nova	Plasencia	Cáceres

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Extremadura

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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