Physical EnduranceNCT04770987
Lateral Neck Flexor Endurance and Hyperlaxity
An observational study of Physical Endurance and Hypermobility, Joint, run by University of Hartford at 1 site in United States.
Trial summary
The lateral neck flexor endurance test has been proposed to assess for unilateral muscular deficits. It is not known if individuals with hyperlaxity have different muscular endurance than individuals without hyperlaxity. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Endurance, Hypermobility, Joint, Muscular Weakness
- What is being tested?
- lateral neck flexor endurance test
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 16 Jul 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals between the ages of 18-60 with and without systemic hyperlaxity
Who may be able to join
- systemic hyperlaxity of 5 or greater on Beighton Index, healthy age/gender matched controls
Who cannot join
- neck pain that spreads into the arms;
- whiplash injury within the last 6 weeks;
- diagnosed neuropathy or other nervous system disorders;
- a history of spinal surgery in their neck;
- fibromyalgia;
- insulin dependent diabetes;
- involved in legal activity regarding neck pain
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hartford
West Hartford, Connecticut, 06117
About this study
Official title: Lateral Neck Flexor Endurance in Individuals With and Without Systemic Hyperlaxity
The lateral neck flexor endurance test has been proposed to assess for unilateral muscular deficits. It is not known if individuals with hyperlaxity have different muscular endurance than individuals without hyperlaxity.
Read the detailed description
Thirty individuals with systemic hyperlaxity as determined with the Beighton scale will be assessed for lateral neck flexor endurance and compared to age and gender matched controls. Basic demographic information will be collected, and all individuals will report Neck Disability Index (NDI) and Numeric Pain Rating Scales (NPRS) for their neck, as well duration of any neck pain. All participants will then undergo testing of lateral neck flexor muscle endurance, repeated twice on each side. Average hold times will be compared for individuals with hyperlaxity (5 or greater on Beighton scale) and the healthy age and gender matched controls. Analysis will also include covariates of NDI scores, pain scores, and chronicity of symptoms.
- Conditions
- Physical Endurance, Hypermobility, Joint, Muscular Weakness
- Being tested
- lateral neck flexor endurance test
- Keywords
- neck musculature, endurance, tests and measures
- Medical subject headings
- Joint Instability, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral neck flexor endurance testOther
Individuals will maintain the head in a neutral position off the ground in sidelying for as long as possible.
| Study group | Role | What they receive |
|---|---|---|
| hyperlaxity | 30 individuals with systemic hyperlaxity as defined by a score of 5 or greater on the Beighton Hypermobility Scale Receives: Other: lateral neck flexor endurance test | |
| control | 30 healthy, age and gender matched individuals without hyperlaxity Receives: Other: lateral neck flexor endurance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
lateral neck flexor endurance
maximum hold time
Measured: single testing session at enrollment
Secondary outcomes (3)
Beighton Hyperlaxity Scale
Assessment of systemic hyperlaxity, 0-9 points, higher indicates greater hyperlaxity
Measured: at enrollment
Neck Disability Index
Questionnaire assessing impact of neck symptoms on function, 0-100 points, higher score indicates greater disability
Measured: at enrollment
Numeric pain rating scale
assessment of neck pain, 0-10 with higher indicating greater levels of pain
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start26 Feb 2021
- Primary completion16 Jul 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical EnduranceStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hartford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Swanson, PT, DSc, Principal investigator, University of Hartford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770987
- Sponsor's protocol ID
- PRO02021000205
- Status last verified
- Jul 2021
- First submitted
- 22 Feb 2021
- Last updated
- 22 Jul 2021
- 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 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Neck Flexor Endurance in Individuals With and Without Systemic Hyperlaxity
- ClinicalTrials.gov ID
- NCT04770987
- Acronym / sponsor ID
- PRO02021000205
- Conditions
- Physical Endurance, Hypermobility, Joint, Muscular Weakness
- Keywords
- neck musculature, endurance, tests and measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of HartfordUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 25 Feb 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.
The lateral neck flexor endurance test has been proposed to assess for unilateral muscular deficits. It is not known if individuals with hyperlaxity have different muscular endurance than individuals without hyperlaxity.
Detailed description
Thirty individuals with systemic hyperlaxity as determined with the Beighton scale will be assessed for lateral neck flexor endurance and compared to age and gender matched controls. Basic demographic information will be collected, and all individuals will report Neck Disability Index (NDI) and Numeric Pain Rating Scales (NPRS) for their neck, as well duration of any neck pain. All participants will then undergo testing of lateral neck flexor muscle endurance, repeated twice on each side. Average hold times will be compared for individuals with hyperlaxity (5 or greater on Beighton scale) and the healthy age and gender matched controls. Analysis will also include covariates of NDI scores, pain scores, and chronicity of symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperlaxity | – | Other: lateral neck flexor endurance test30 individuals with systemic hyperlaxity as defined by a score of 5 or greater on the Beighton Hypermobility Scale |
| control | – | Other: lateral neck flexor endurance test30 healthy, age and gender matched individuals without hyperlaxity |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals between the ages of 18-60 with and without systemic hyperlaxity
Key inclusion criteria (1 listed)
- systemic hyperlaxity of 5 or greater on Beighton Index, healthy age/gender matched controls
Key exclusion criteria (7 listed)
- neck pain that spreads into the arms;
- whiplash injury within the last 6 weeks;
- diagnosed neuropathy or other nervous system disorders;
- a history of spinal surgery in their neck;
- fibromyalgia;
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 |
|---|---|---|
| lateral neck flexor endurance testIndividuals will maintain the head in a neutral position off the ground in sidelying for as long as possible. | Other | control, hyperlaxity |
Primary outcome
lateral neck flexor endurance
Time frame: single testing session at enrollment
maximum hold time
3 secondary outcomes
Beighton Hyperlaxity Scale
Time frame: at enrollment
Neck Disability Index
Time frame: at enrollment
Numeric pain rating scale
Time frame: at enrollment
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 22 Jul 2021.
- 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.
Brian Swanson, PT, DSc principal investigator
University of Hartford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Endurance and Hypermobility, Joint, run by University of Hartford at 1 site in United States.
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 1 inclusion and 7 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 22 Jul 2021. 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 United States. 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?
lateral neck flexor endurance (time frame: single testing session at enrollment). 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 22 Jul 2021; AzTrials last refreshed its copy on 27 Oct 2026.