Neck Muscle IssueNCT04784195
Functional and Morphological Characteristics of Neck Muscles in Acrobatic Skydivers
An observational study of Neck Muscle Issue and Sternocleidomastoid; Contracture, run by Universidad de Murcia.
Trial summary
An observational cohort study, following the Strengthening the Reporting of Observational Studies in Epidemiology(STROBE) guidelines. Two groups will be examined, a group composed by spanish acrobatic skydivers and a control group composed by general physically active population(GPAP). Read more about this study
- Who is it for?
- Ages Up to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Muscle Issue, Sternocleidomastoid; Contracture, Deltoid Muscle Strain
- What is being tested?
- Observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 3 Mar 2021to 30 May 2021
- Phase
- Observational
- 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 Up to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants with a high level of physical activity and actualy involved in skydiving practices.
Who may be able to join
- pain-free in the neck area in the last three months
- didn't actually take any drugs that can interfere with muscle strength
Who cannot join
- participants that not mached with the skydivers caracteristics
About this study
Official title: Functional and Morphological Characteristics of Neck Muscles in Acrobatic Skydivers: an Observational Prospective Cohort Study
An observational cohort study, following the Strengthening the Reporting of Observational Studies in Epidemiology(STROBE) guidelines.
Two groups will be examined, a group composed by spanish acrobatic skydivers and a control group composed by general physically active population(GPAP).
Read the detailed description
Two groups will be examined for veryfing the morfology and the function of neck muscles.
The profesional group composed by spanish acrobatic skydivers and a general group composed by general physically active population(GPAP). Both groups are matched at known confounder outcomes such as: physical activity level, age, sex, body weight and history of neck pain. Frequency matching will be carried out, subjects will be matched on known confounders.
- Being tested
- Observation
- Medical subject headings
- Congenital torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationBehavioural
Verification of morfology and functionality of neck muscles
| Study group | Role | What they receive |
|---|---|---|
| Profesional acrobatics | Profesional Acrobatic Skyedivers as the cort group Receives: Behavioral: Observation | |
| General active participations | Adults with meched caracteristics with the profesional acrobatics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anticipatory postural adjustment
Electromyographic test in ms.The myoelectric signal will be recorded by using mDurance R system (mDurance Solutions SL, Granada). The electrodes used will be pre-gelled Ag/AgCl with a diameter of 10mm and an interelectrode distance of 20mm.
Measured: 10 minutes
Isometric cervical strength
Measured in newton with heandheld Dynamometer (model 001165, Lafayette Instrument Company)
Measured: 10 minutes
Neck flexor and extensor endurance
Measures in seconds with a stopwatch
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start3 Mar 2021 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Muscle IssueStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Reina Abellan, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784195
- Sponsor's protocol ID
- CE102001
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Morphological Characteristics of Neck Muscles in Acrobatic Skydivers: an Observational Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04784195
- Acronym / sponsor ID
- CE102001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 3 Mar 2021 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 5 Mar 2021 (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.
An observational cohort study, following the Strengthening the Reporting of Observational Studies in Epidemiology(STROBE) guidelines.
Two groups will be examined, a group composed by spanish acrobatic skydivers and a control group composed by general physically active population(GPAP).
Detailed description
Two groups will be examined for veryfing the morfology and the function of neck muscles.
The profesional group composed by spanish acrobatic skydivers and a general group composed by general physically active population(GPAP). Both groups are matched at known confounder outcomes such as: physical activity level, age, sex, body weight and history of neck pain. Frequency matching will be carried out, subjects will be matched on known confounders.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Profesional acrobatics | – | Behavioral: ObservationProfesional Acrobatic Skyedivers as the cort group |
| General active participations | – | –Adults with meched caracteristics with the profesional acrobatics |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants with a high level of physical activity and actualy involved in skydiving practices.
Key inclusion criteria (2 listed)
- pain-free in the neck area in the last three months
- didn't actually take any drugs that can interfere with muscle strength
Key exclusion criteria (1 listed)
- participants that not mached with the skydivers caracteristics
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 |
|---|---|---|
| ObservationVerification of morfology and functionality of neck muscles | Behavioural | Profesional acrobatics |
Primary outcome
Anticipatory postural adjustment
Time frame: 10 minutes
Electromyographic test in ms.The myoelectric signal will be recorded by using mDurance R system (mDurance Solutions SL, Granada). The electrodes used will be pre-gelled Ag/AgCl with a diameter of 10mm and an interelectrode distance of 20mm.
Isometric cervical strength
Time frame: 10 minutes
Measured in newton with heandheld Dynamometer (model 001165, Lafayette Instrument Company)
Neck flexor and extensor endurance
Time frame: 10 minutes
Measures in seconds with a stopwatch
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Muscle Issue and Sternocleidomastoid; Contracture, run by Universidad de Murcia.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Anticipatory postural adjustment (time frame: 10 minutes). The study lists 3 primary outcomes in all. 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 11 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.