- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02806622
Comparison of Hip Range of Motion Values Among NCAA Division II Collegiate Athletes
Přehled studie
Postavení
Podmínky
Detailní popis
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).
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Healthy student collegiate athletes
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Division II Collegiate Athletes
Student athletes (18-45) currently enrolled and participating on a sports team.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Hip Joint Internal and External Rotation ROM
Časové okno: Baseline
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Baseline
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Scott W Cheatham, DPT, PhD, California State University, Dominguez Hills
Publikace a užitečné odkazy
Obecné publikace
- 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.
- Prather 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. Erratum In: PM R. 2011 Mar;3(3):286.
- Krause 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.
- Roach 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 16-208
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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