- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02167399
Smart Phone as a Screening and Evaluation Tool to Identify Knee Valgus During Dynamic Activities
22. desember 2014 oppdatert av: Mitchell Selhorst
Evaluation of the Use of the Smart Phone as a Screening and Evaluation Tool to Identify Knee Valgus During Dynamic Activities.
Evidence supports the use of two dimensional video analysis to assess the presence of dynamic knee valgus during generally used screening tasks, however there is limited evidence to support the use of the various smart phone applications as a time and money saving option for clinic use .
Subjects that present to the clinic and display dynamic valgus at the knee during the lateral step down test will be given the option to participate in the study.
If they consent to the study they will be evaluated with 2-Dimensional video analysis to determine the amount of valgus present at the knee during the lateral step down test.
The subject will also have the smart phone attached to their lower leg and the amount of valgus will be concurrently measured by the selected application.
The primary objective of this study is to determine the validity of an application on the smart phone to provide an objective measure of dynamic knee valgus.
The secondary objective of this study is to determine the possibility of the use of the application as a source of feedback during neuromuscular re-education training in order to decrease or eliminate a subject's dynamic valgus collapse and subsequently decreased their risk for future injury.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
25
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ohio
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Westerville, Ohio, Forente stater, 43082
- Nationwide Children's Hospital Sports and Ortho PT Westerville
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
13 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
physical therapy clinic
Beskrivelse
Inclusion Criteria:
- Willingness to participate
- ability to perform a single leg squat, drop jump, and single leg drop without pain
Exclusion Criteria:
- lower extremity injury within 6 months prior to testing
- history of lower extremity surgery
- lower extremity weight bearing restrictions
- inability to follow directions
- neoprene/latex allergy
- Adhesive allergy
- Current neurological or developmental condition
- inability to attend follow-up session
- actively receiving Physical Therapy intervention for varus/valgus impairment
- Current pregnancy
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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smart phone inclinometer
For the smart phone analysis we will be using the tilt meter application which is a digital inclinometer application available on the I phone.
The phone will be placed in the vertical position utilizing the bubble level feature of the application.
The application will be set to display measurements to the closest tenth of the degree, set to log measurements every 0.2 seconds.
The subject will stand with knee extended to 0 degrees and quadriceps muscle activated and upper extremity support on opposite side of stance limb.
The phone will be placed in the vertical position on the anterior portion of the middle third of the subject's thigh attached using double sided adhesive tape.
Being placed as close as possible to level when attached to the anterior thigh with subject in single limb stance with a reading of less than 1 deg as minimum for correct set-up prior to testing.
Immediately prior to testing recording will be initiated logging measurements for later assessment.
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2-D video analysis
two dimensional video analysis by first placing markers on the subject at the midpoint of the femoral condyles, midpoint of the ankle malleoli, and the proximal thigh along a line from the anterior superior iliac spine (ASIS) to the knee marker.
Testing will take place in front of a digital video camera with tape on the floor to give a reference point for the subject being tested.
Participants will be tested twice on day 1 and then again 5-9 days later.
Subjects will be allowed 2-3 practice trials prior to each test in order to allow the subject to feel comfortable with each test.
Following the practice trials the subject will perform 3 trials of each test on bilateral lower extremities.
This set up was consistent with the set up by Munro et al.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Agreement in Dynamic lower extremity valgus angles during single leg squat
Tidsramme: Baseline
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Patient's dynamic lower extremity valgus during single leg squat will be measured using both 2-D video analysis and smart phone inclinometer analysis.
Measurements of 2-D and smart phone will be taken at the same time.
Analysis will be repeated at 2nd visit to assess the reliability of the measurements
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Baseline
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Agreement in Dynamic lower extremity valgus angles during drop jump
Tidsramme: Baseline
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Patient's dynamic lower extremity valgus during a drop jump from a 12 inch step will be measured using both 2-D video analysis and smart phone inclinometer analysis.
Measurements of 2-D and smart phone will be taken at the same time.
Analysis will be repeated at 2nd visit to assess the reliability of the measurements
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Baseline
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Agreement in Dynamic lower extremity valgus angles during single leg landing drop jump
Tidsramme: Baseline
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Patient's dynamic lower extremity valgus during a single leg drop jump from a 12 inch step will be measured using both 2-D video analysis and smart phone inclinometer analysis.
Measurements of 2-D and smart phone will be taken at the same time.
Analysis will be repeated at 2nd visit to assess the reliability of the measurements
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Baseline
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mitchell C Selhorst, DPT, Nationwide Children's Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Munro A, Herrington L, Carolan M. Reliability of 2-dimensional video assessment of frontal-plane dynamic knee valgus during common athletic screening tasks. J Sport Rehabil. 2012 Feb;21(1):7-11. doi: 10.1123/jsr.21.1.7. Epub 2011 Nov 15.
- Swenson DM, Collins CL, Fields SK, Comstock RD. Epidemiology of U.S. high school sports-related ligamentous ankle injuries, 2005/06-2010/11. Clin J Sport Med. 2013 May;23(3):190-6. doi: 10.1097/JSM.0b013e31827d21fe.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2014
Primær fullføring (Faktiske)
1. juni 2014
Studiet fullført (Faktiske)
1. september 2014
Datoer for studieregistrering
Først innsendt
10. juni 2014
Først innsendt som oppfylte QC-kriteriene
18. juni 2014
Først lagt ut (Anslag)
19. juni 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. desember 2014
Sist bekreftet
1. desember 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB14-00222
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