NCT04770987

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

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

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

February 26, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

February 22, 2021

Last Update Submit

July 21, 2021

Conditions

Keywords

neck musculatureendurancetests and measures

Outcome Measures

Primary Outcomes (1)

  • lateral neck flexor endurance

    maximum hold time

    single testing session at enrollment

Secondary Outcomes (3)

  • Beighton Hyperlaxity Scale

    at enrollment

  • Neck Disability Index

    at enrollment

  • Numeric pain rating scale

    at enrollment

Study Arms (2)

hyperlaxity

30 individuals with systemic hyperlaxity as defined by a score of 5 or greater on the Beighton Hypermobility Scale

Other: lateral neck flexor endurance test

control

30 healthy, age and gender matched individuals without hyperlaxity

Other: lateral neck flexor endurance test

Interventions

Individuals will maintain the head in a neutral position off the ground in sidelying for as long as possible.

controlhyperlaxity

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals between the ages of 18-60 with and without systemic hyperlaxity

You may qualify if:

  • systemic hyperlaxity of 5 or greater on Beighton Index, healthy age/gender matched controls

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hartford

West Hartford, Connecticut, 06117, United States

Location

MeSH Terms

Conditions

Joint InstabilityMuscle Weakness

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesMuscular DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Brian Swanson, PT, DSc

    University of Hartford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 25, 2021

Study Start

February 26, 2021

Primary Completion

July 16, 2021

Study Completion

July 16, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations