- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03734133
Electromyography Evaluation of the Impacts of Different Insoles in the Activity Patterns of the Lower Limb Muscles
November 30, 2018 updated by: César Calvo Lobo, Universidad de León
Electromyography Evaluation of the Impacts of Different Insoles in the Activity Patterns of the Lower Limb Muscles: A Cross-over Quasi-experimental Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain, 28040
- Universidad Complutense de Madrid
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects
- Motorcycle riders
Exclusion Criteria:
- Musculoskeletal conditions
- Neurological alterations
- Systemic diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Foot orthoses
Different foot orthoses
|
Different foot insoles of different hardness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Superficial electromyography peak measured as percentage
Time Frame: Change from Baseline superficial electromyography peak at 5 minutes
|
Superficial electromyography activity peak of the vastus lateralis muscle
|
Change from Baseline superficial electromyography peak at 5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 28, 2018
Primary Completion (Actual)
November 30, 2018
Study Completion (Actual)
November 30, 2018
Study Registration Dates
First Submitted
November 5, 2018
First Submitted That Met QC Criteria
November 6, 2018
First Posted (Actual)
November 7, 2018
Study Record Updates
Last Update Posted (Actual)
December 3, 2018
Last Update Submitted That Met QC Criteria
November 30, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- EMG_foot orthoses
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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