- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02167399
Smart Phone as a Screening and Evaluation Tool to Identify Knee Valgus During Dynamic Activities
22. december 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
25
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ohio
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Westerville, Ohio, Forenede Stater, 43082
- Nationwide Children's Hospital Sports and Ortho PT Westerville
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
13 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Mitchell C Selhorst, DPT, Nationwide Children's Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2014
Primær færdiggørelse (Faktiske)
1. juni 2014
Studieafslutning (Faktiske)
1. september 2014
Datoer for studieregistrering
Først indsendt
10. juni 2014
Først indsendt, der opfyldte QC-kriterier
18. juni 2014
Først opslået (Skøn)
19. juni 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. december 2014
Sidst verificeret
1. december 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB14-00222
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Benskader
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Mathematica Policy Research, Inc.Afsluttet
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University of British ColumbiaCanadian Institutes of Health Research (CIHR); BC Children's Hospital Research... og andre samarbejdspartnereRekrutteringForældrepraksis | Co-forældre praksis | Børns spise- og diætadfærd | Barnets skærmtid | Barn Fysisk aktivitet/aktiv leg/udendørs legCanada
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Region SkaneAfsluttetSportsrelateret hjernerystelse, selektiv hoved-halskøling, tilbage til legSverige
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Bezmialem Vakif UniversityAfsluttetLeg og LegetøjKalkun
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Amsterdam UMC, location VUmcUniversity of Southern Denmark, Odense, Denmark; Fundación Instituto Investigación... og andre samarbejdspartnereTilmelding efter invitationAktiv udendørs leg og relateret sund kostadfærdHolland, Polen, Danmark, Tyskland, Spanien
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Ege UniversityAfsluttetAngst | Frygt | Terapeutisk legKalkun
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Istituto Ortopedico GaleazziAfsluttetAtletiske skader | Single Leg Squat Performance
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Kocaeli UniversityKahramanmaraş İstiklal UniversityAfsluttetSygepleje | Terapeutisk leg | Psykosocialt velværeTyrkiet (Türkiye)
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Clinica ARS MedicaIkke rekrutterer endnuRestless Leg Syndrome (RLS)Schweiz
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Necmettin Erbakan UniversityAfsluttet