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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04836650
Enrollment
40
Registered
2021-04-08
Start date
2021-04-06
Completion date
2021-04-22
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscular Activity, Postural Stability

Keywords

Metatarsal Bar, Insoles, Postural stability, Electromyograph Activity

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.

Interventions

DIAGNOSTIC_TESTPostural 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_TESTMuscular 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.

Sponsors

Universidad de Extremadura
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change of postural balanceFrom baseline to 10 minutesThe 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 activityFrom baseline to 10 minutesThe 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026