Disorder of Hip JointNCT02806622
Comparison of Hip Range of Motion Values Among NCAA Division II Collegiate Athletes
An observational study of Disorder of Hip Joint, run by California State University, Dominguez Hills.
Trial summary
The purpose of this study is to compare hip passive range of motion (ROM) among division II collegiate athletes in order to obtain normative data for future research. The investigators hypothesize that there will be a difference in passive hip ROM among the different genders and sports. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Hip Joint
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jan 2017
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Division II collegiate athletes (18-45) currently enrolled in school and participating on a sports team.
Who may be able to join
- Healthy student collegiate athletes
Who cannot join
- Presence of musculoskeletal, systemic or metabolic diseases that would affect lower extremity joint ROM or muscle function
- Presence of any current or past muscle or joint pathology of the hip, knee, and/or ankle that would affect lower extremity joint ROM or muscle function
- Inability to avoid exercise 4 hours prior to testing
- Inability to avoid medications that may affect the outcome of lower extremity joint ROM or muscle function
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to compare hip passive range of motion (ROM) among division II collegiate athletes in order to obtain normative data for future research. The investigators hypothesize that there will be a difference in passive hip ROM among the different genders and sports.
Read the detailed description
Currently there is no normative data for hip passive ROM in apparently healthy NCAA division II collegiate athletes. This study will be the first study to develop preliminary normative data of hip passive ROM.
One hundred (N=100) student athletes (18-45 years) from California State University Dominguez Hills (CSUDH) will be recruited for this study via convenience sampling. Data collection will take place in the CSUDH sports medicine laboratory. Prior to testing, participants will fill out a screening questionnaire with questions that represent the exclusion criteria which will be used to determine ineligibility for this study.
Prior to participant recruitment and enrollment, a pilot study will be done on 10 participants to establish rater reliability using the methods mentioned below. After acceptable reliability is achieved, recruitment and enrollment will continue.
Participants who meet the inclusion criteria and consent to participate will be enrolled in the study. Participants will read and sign a CSUDH approved consent form prior to beginning data collection. Following consent, participants will also fill out a questionnaire to provide demographic information which includes age, height, weight, and leg dominance.
Following completion of the paperwork, all participants will undergo testing which will be conducted between the hours of 8am and 4pm. Each data collection session will last for approximately 20 minutes. Bilateral hip passive ROM data will be collected using the Noraxon computerized motion system. Participants will be lying in different positions on an examination table while the hip joints and lower extremities are moved into different positions and measured by the device which will touch the skin. Data will be collected and monitored by the examiner using the computerized system. The data collection protocol for both lower extremities are as follows:
- Supine measures (passive): hip external rotation, hip internal rotation
- Rest: 5-minute delay
- Seated measures (passive): hip external rotation, hip internal rotation
- Rest: 5-minute delay
- Prone measurements (passive): hip external rotation, hip internal rotation
Collected data will be transferred to SPSS v.22 (IBM SPSS, Chicago, IL). Means,standard deviations, 95% confidence intervals (95% CI), and ranges for participant descriptive data will be calculated. Passive Hip ROM values will be presented using degrees and percentages. Athlete gender and sport differences will be calculated using the ANOVA statistic. The p-value will be considered significant at the .05 level using a two-tailed test (α2 =.05).
- Conditions
- Disorder of Hip Joint
- Keywords
- Sports, University, Lower Extremity, Hip Joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Division II Collegiate Athletes | Student athletes (18-45) currently enrolled and participating on a sports team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Joint Internal and External Rotation ROM
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Disorder of Hip JointStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California State University, Dominguez Hills
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Cheatham, California State University, Dominguez Hills
- Investigators
- Scott W Cheatham, DPT, PhD, Principal investigator, California State University, Dominguez Hills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806622
- Sponsor's protocol ID
- 16-208
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Shimamura KK, Cheatham S, Chung W, Farwell D, De la Cruz F, Goetz J, Lindblom K, Powers D. Regional interdependence of the hip and lumbo-pelvic region in divison ii collegiate level baseball pitchers: a preliminary study. Int J Sports Phys Ther. 2015 Feb;10(1):1-12.
PubMed 25709857Prather H, Harris-Hayes M, Hunt DM, Steger-May K, Mathew V, Clohisy JC. Reliability and agreement of hip range of motion and provocative physical examination tests in asymptomatic volunteers. PM R. 2010 Oct;2(10):888-95. doi: 10.1016/j.pmrj.2010.05.005.
PubMed 20970757Krause DA, Hollman JH, Krych AJ, Kalisvaart MM, Levy BA. Reliability of hip internal rotation range of motion measurement using a digital inclinometer. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2562-7. doi: 10.1007/s00167-014-3096-0. Epub 2014 Jun 11.
PubMed 24912575Roach S, San Juan JG, Suprak DN, Lyda M. Concurrent validity of digital inclinometer and universal goniometer in assessing passive hip mobility in healthy subjects. Int J Sports Phys Ther. 2013 Oct;8(5):680-8.
PubMed 24175147
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hip Range of Motion Values Among NCAA Division II Collegiate Athletes
- ClinicalTrials.gov ID
- NCT02806622
- Acronym / sponsor ID
- 16-208
- Conditions
- Disorder of Hip Joint
- Keywords
- Sports, University, Lower Extremity, Hip Joint
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- California State University, Dominguez HillsUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 20 Jun 2016 (estimated)
- 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 purpose of this study is to compare hip passive range of motion (ROM) among division II collegiate athletes in order to obtain normative data for future research. The investigators hypothesize that there will be a difference in passive hip ROM among the different genders and sports.
Detailed description
Currently there is no normative data for hip passive ROM in apparently healthy NCAA division II collegiate athletes. This study will be the first study to develop preliminary normative data of hip passive ROM.
One hundred (N=100) student athletes (18-45 years) from California State University Dominguez Hills (CSUDH) will be recruited for this study via convenience sampling. Data collection will take place in the CSUDH sports medicine laboratory. Prior to testing, participants will fill out a screening questionnaire with questions that represent the exclusion criteria which will be used to determine ineligibility for this study.
Prior to participant recruitment and enrollment, a pilot study will be done on 10 participants to establish rater reliability using the methods mentioned below. After acceptable reliability is achieved, recruitment and enrollment will continue.
Participants who meet the inclusion criteria and consent to participate will be enrolled in the study. Participants will read and sign a CSUDH approved consent form prior to beginning data collection. Following consent, participants will also fill out a questionnaire to provide demographic information which includes age, height, weight, and leg dominance.
Following completion of the paperwork, all participants will undergo testing which will be conducted between the hours of 8am and 4pm. Each data collection session will last for approximately 20 minutes. Bilateral hip passive ROM data will be collected using the Noraxon computerized motion system. Participants will be lying in different positions on an examination table while the hip joints and lower extremities are moved into different positions and measured by the device which will touch the skin. Data will be collected and monitored by the examiner using the computerized system. The data collection protocol for both lower extremities are as follows:
- Supine measures (passive): hip external rotation, hip internal rotation
- Rest: 5-minute delay
- Seated measures (passive): hip external rotation, hip internal rotation
- Rest: 5-minute delay
- Prone measurements (passive): hip external rotation, hip internal rotation
Collected data will be transferred to SPSS v.22 (IBM SPSS, Chicago, IL). Means,standard deviations, 95% confidence intervals (95% CI), and ranges for participant descriptive data will be calculated. Passive Hip ROM values will be presented using degrees and percentages. Athlete gender and sport differences will be calculated using the ANOVA statistic. The p-value will be considered significant at the .05 level using a two-tailed test (α2 =.05).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Division II Collegiate Athletes | – | –Student athletes (18-45) currently enrolled and participating on a sports team. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Division II collegiate athletes (18-45) currently enrolled in school and participating on a sports team.
Key inclusion criteria (1 listed)
- Healthy student collegiate athletes
Key exclusion criteria (4 listed)
- Presence of musculoskeletal, systemic or metabolic diseases that would affect lower extremity joint ROM or muscle function
- Presence of any current or past muscle or joint pathology of the hip, knee, and/or ankle that would affect lower extremity joint ROM or muscle function
- Inability to avoid exercise 4 hours prior to testing
- Inability to avoid medications that may affect the outcome of lower extremity joint ROM or muscle function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hip Joint Internal and External Rotation ROM
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Background: PubMed 25709857Shimamura KK, Cheatham S, Chung W, Farwell D, De la Cruz F, Goetz J, Lindblom K, Powers D. Regional interdependence of the hip and lumbo-pelvic region in divison ii collegiate level baseball pitchers: a preliminary study. Int J Sports Phys Ther. 2015 Feb;10(1):1-12.
- Background: PubMed 20970757Prather H, Harris-Hayes M, Hunt DM, Steger-May K, Mathew V, Clohisy JC. Reliability and agreement of hip range of motion and provocative physical examination tests in asymptomatic volunteers. PM R. 2010 Oct;2(10):888-95. doi: 10.1016/j.pmrj.2010.05.005.
- Background: PubMed 24912575Krause DA, Hollman JH, Krych AJ, Kalisvaart MM, Levy BA. Reliability of hip internal rotation range of motion measurement using a digital inclinometer. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2562-7. doi: 10.1007/s00167-014-3096-0. Epub 2014 Jun 11.
- Background: PubMed 24175147Roach S, San Juan JG, Suprak DN, Lyda M. Concurrent validity of digital inclinometer and universal goniometer in assessing passive hip mobility in healthy subjects. Int J Sports Phys Ther. 2013 Oct;8(5):680-8.
- Individual participant dataSharing planned: Undecided
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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.
Scott W Cheatham, DPT, PhD principal investigator
California State University, Dominguez Hills
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Hip Joint, run by California State University, Dominguez Hills.
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 4 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 20 Jun 2016. 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?
Contact Scott W Cheatham, DPT, PhD (310 243-3794, scheatham@csudh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip Joint Internal and External Rotation ROM (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02806622, which also lists 4 linked publications.
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 20 Jun 2016.