- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02985788
Self Digital Photography for Assessing Elbow Range of Motion
11. december 2018 opdateret af: Shawn W. O'Driscoll, Mayo Clinic
Validation of Self Digital Photography for Assessing Elbow Range of Motion
Loss of elbow range of motion can significantly affect activities of daily living.
Measuring elbow range of motion is critical for tracking post surgical outcomes.
This study seeks to validate the ability to validate self photography as a means of followup through long distance correspondence.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Loss of elbow range of motion is common after trauma and can significantly affect activities of daily living.
Patients across the country travel to tertiary referral centers to have this problem addressed.
Followup is critical and can often be difficult given distances between patients home and their healthcare provider.
Measuring postoperative outcomes requires accurate and reliable documentation of range of motion.
Previously, the investigators have validated digital photography as a means of accurately measuring elbow range of motion.
In that study, photographs were taken by a non-professional photographer.
With the advance in personal technology, patients now have the ability to take photos themselves.
This study seeks to validate self photography, which will ultimately improve patient follow up and improve clinical monitoring
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
50
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All patients who have an elbow contracture in the sagittal plane
Beskrivelse
Inclusion Criteria:
- Elbow contracture in the sagittal place
Exclusion Criteria:
- Unable to read English
- Unable to forward flex shoulder to 90 degrees or hold their shoulder at 90 degrees for the duration of the examination
- Unable to tolerate the exercise due to pain
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 |
|---|
|
Video Instructions
Instructions on how to take a flexion/extension picture will be delivered in video format.
These instructions will be followed by written instruction on how to take pictures examining pronation/supination.
|
|
Written instructions
Instructions on how to take a flexion/extension picture will be delivered in a written, on paper format.
These instructions will be followed by written instruction on how to take pictures examining pronation/supination.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Digital photo-based elbow range of motion measurement compared to traditional goniometry
Tidsramme: up to 2 months
|
Patients will follow instructions to take a photograph of themselves capturing elbow range of motion (flexion, extension, supination and pronation).
Elbow range of motion will then be measured clinically with a goniometer.
Patient's active participation will be 1 day.
Range of motion will be measured off of photographs 1 month after capturing pictures and repeated 2 weeks later
|
up to 2 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Shawn O'Driscoll, PhD MD, Mayo Clinic
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. september 2016
Primær færdiggørelse (Faktiske)
15. november 2018
Studieafslutning (Faktiske)
15. november 2018
Datoer for studieregistrering
Først indsendt
8. november 2016
Først indsendt, der opfyldte QC-kriterier
5. december 2016
Først opslået (Skøn)
7. december 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. december 2018
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13-003378
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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 .