Electromyography Evaluation of the Impacts of Different Insoles in the Activity Patterns of the Lower Limb Muscles

Sponsor

Universidad de León (Other)

Overall Status

Completed

CT.gov ID

NCT03734133

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

137

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this research is to demonstrate that the use of insoles of different hardness in motorcycle riders may cause variations in the electromyographic activity of the lower limb muscles during the race. This study is a cross-over quasi-experimental study. Nine motorcycle riders were recruited. Electromyographic activity of the lower limb muscles is recorded under different insole types.

Condition or Disease	Intervention/Treatment	Phase
Electromyography Muscles Foot Orthoses	Other: Foot insoles	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Electromyography Evaluation of the Impacts of Different Insoles in the Activity Patterns of the Lower Limb Muscles: A Cross-over Quasi-experimental Study

Actual Study Start Date :

Nov 28, 2018

Actual Primary Completion Date :

Nov 30, 2018

Actual Study Completion Date :

Nov 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Foot orthoses Different foot orthoses	Other: Foot insoles Different foot insoles of different hardness

Arm

Intervention/Treatment

Experimental: Foot orthoses

Different foot orthoses

Other: Foot insoles

Different foot insoles of different hardness

Outcome Measures

Primary Outcome Measures

Superficial electromyography peak measured as percentage [Change from Baseline superficial electromyography peak at 5 minutes]
Superficial electromyography activity peak of the vastus lateralis muscle

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy subjects
Motorcycle riders

Exclusion Criteria:

Musculoskeletal conditions
Neurological alterations
Systemic diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad complutense de Madrid	Madrid		Spain	28040

Sponsors and Collaborators

Universidad de León

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

César Calvo Lobo, Principal Investigator, Universidad de León

ClinicalTrials.gov Identifier:

NCT03734133

Other Study ID Numbers:

EMG_foot orthoses

First Posted:

Nov 7, 2018

Last Update Posted:

Dec 3, 2018

Last Verified:

Nov 1, 2018

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:

Study Results

No Results Posted as of Dec 3, 2018