NCT03734133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

November 28, 2018

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

2 days

First QC Date

November 5, 2018

Last Update Submit

November 30, 2018

Conditions

ElectromyographyMusclesFoot Orthoses

Outcome Measures

Primary Outcomes (1)

  • Superficial electromyography peak measured as percentage

    Superficial electromyography activity peak of the vastus lateralis muscle

    Change from Baseline superficial electromyography peak at 5 minutes

Study Arms (1)

Foot orthoses

EXPERIMENTAL

Different foot orthoses

Other: Foot insoles

Interventions

Foot insolesOTHER

Different foot insoles of different hardness

Foot orthoses

Eligibility Criteria

Age14 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy subjects
  • Motorcycle riders

You may not qualify if:

  • Musculoskeletal conditions
  • Neurological alterations
  • Systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad complutense de Madrid

Madrid, 28040, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 7, 2018

Study Start

November 28, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

December 3, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)