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Effect of Postural Insoles on Stability and Leg Muscular Activity

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ClinicalTrials.gov Identifier: NCT04836650
Recruitment Status : Completed
First Posted : April 8, 2021
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Alfonso Martínez Nova, Universidad de Extremadura

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : April 6, 2021
Actual Primary Completion Date : April 15, 2021
Actual Study Completion Date : April 22, 2021

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.




Primary Outcome Measures :
  1. Change of postural balance [ Time Frame: 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

  2. Change of muscular activity [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04836650


Locations
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Spain
Alfonso Martínez Nova
Plasencia, Cáceres, Spain, 10600
Sponsors and Collaborators
Universidad de Extremadura
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Responsible Party: Alfonso Martínez Nova, Clinical Professor, Universidad de Extremadura
ClinicalTrials.gov Identifier: NCT04836650    
Other Study ID Numbers: FOSSIL
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alfonso Martínez Nova, Universidad de Extremadura:
Metatarsal Bar
Insoles
Postural stability
Electromyograph Activity