ElectromyographyNCT03734133
Electromyography Evaluation of the Impacts of Different Insoles in the Activity Patterns of the Lower Limb Muscles
A study testing Foot insoles in people with Electromyography and Muscles, run by Universidad de León at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Electromyography, Muscles, Foot Orthoses
- What is being tested?
- Foot insoles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSpain
- Study dates
- 28 Nov 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy subjects
- Motorcycle riders
Who cannot join
- Musculoskeletal conditions
- Neurological alterations
- Systemic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Electromyography, Muscles, Foot Orthoses
- Being tested
- Foot insoles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot insolesOther
Different foot insoles of different hardness
| Study group | Role | What they receive |
|---|---|---|
| Foot orthoses | Experimental | Different foot orthoses Receives: Other: Foot insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superficial electromyography peak measured as percentage
Superficial electromyography activity peak of the vastus lateralis muscle
Measured: Change from Baseline superficial electromyography peak at 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start28 Nov 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectromyographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Calvo Lobo, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734133
- Sponsor's protocol ID
- EMG_foot orthoses
- Status last verified
- Nov 2018
- First submitted
- 5 Nov 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03734133
- Acronym / sponsor ID
- EMG_foot orthoses
- Conditions
- Electromyography, Muscles, Foot Orthoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foot orthoses | Experimental | Other: Foot insolesDifferent foot orthoses |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy subjects
- Motorcycle riders
Key exclusion criteria (3 listed)
- Musculoskeletal conditions
- Neurological alterations
- Systemic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot insolesDifferent foot insoles of different hardness | Other | Foot orthoses |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot insoles in people with Electromyography and Muscles, run by Universidad de León at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superficial electromyography peak measured as percentage (time frame: Change from Baseline superficial electromyography peak at 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2018.