Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Insole Sensor to Determine Optimal Limb Loading

24. oktober 2017 opdateret af: David Rothberg, University of Utah

Development and Clinical Trial of an Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of OTA Type 42IIIB and IIIC Lower Extremity Fractures

The purpose of this study is to use a novel load monitoring technology to correlate limb loading to OTA type 42IIIB and IIIC tibial fracture outcomes. This study will be the first to collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing. To meet this purpose, two specific aims have been developed.

Specific Aim 1: Preclinical validation of a load-monitoring insole

The Hitchcock laboratory has overcome the greatest technical hurdle for continuous limb load monitoring: development of load sensor technology that is affordable, accurate and capable of monitoring for over four weeks. To develop this sensor technology into a load-monitoring insole, the Hitchcock lab will incorporate consumer type electronics into the design, including a microprocessor, battery, and data storage media.

Following construction of a functional load-monitoring insole, a pilot human study with orthopaedic trauma patients from the University of Utah (N=20) will be conducted to identify modes of device failure, improve device interfacing and develop data handling protocols and software for the clinical arm of the proposed study.

Specific Aim 2: Conduct a prospective, direct observational cohort study.

Thirty (30) open tibial fracture patients will be recruited at two centers: University of Utah (N=15) and William Beaumont Army Medical Center (N=15). Participants will wear a walking boot instrumented with the load-monitoring insole that will continuously record limb loading and serve as a step counter. X-rays collected at standard-of-care follow-up visits will be used by Drs. Kubiak and Orr to subjectively evaluate fracture healing. A questionnaire regarding subjective perception of patient compliance will be collected at the first and last follow-up visits. Data collected from the insole sensor will be correlated to objective measures of fracture healing and subjective measures of patient compliance to determine the effect of patient limb loading on injury outcome. The Hitchcock laboratory will develop software to process and summarize data from the load monitoring insole and continually improve human interfacing factors of the load monitoring insole based off of feedback from the clinical team and study participants.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

19

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84108
        • University of Utah

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 til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients who present to the University of Utah with an Open Tibial Fractures.

Beskrivelse

Inclusion Criteria:

Specific Aim 1 Inclusion Criteria

  • Patient is 18 years of age or older
  • Patient has below the knee fracture
  • Patient speaks English
  • Patient weighs between 100 and 250 pounds
  • Patient lives in close enough proximity to the the hospital to return for all appointments (~100 miles)

Specific Aim 2 Inclusion Criteria

  • Patient is 18 years of age or older
  • Patient has a tibia fracture
  • Patient speaks English
  • Patient weighs between 100 and 250 pounds
  • Patient lives in close enough proximity to the the hospital to return for all appointments (~100 miles)

Exclusion Criteria:

Specific Aim 1 Exclusion Criteria

  • Patient is younger than 18 years of age
  • Patient does not have a below the knee fracture
  • Patient does not speak English
  • Patient weighs less than 100 pounds or more than 250 pounds
  • Patient does not live in close enough proximity to the hospital to return for all appointments (~100 miles)
  • Patient has another fracture that will alter his/her weight bearing status

Specific Aim 2 Exclusion Criteria

  • Patient is younger than 18 years of age
  • Patient does not have a tibia fracture
  • Patient does not speak English
  • Patient weighs less than 100 pounds or more than 250 pounds
  • Patient does not live in close enough proximity to the hospital to return for all appointments (~100 miles)
  • Patient has another fracture that will alter his/her weight bearing status

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Activity Measure (PAM-13) Questionnaire
Tidsramme: Follow Up Visits up to 1-Year
A subjective evaluation of perceived compliance with physician instruction
Follow Up Visits up to 1-Year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
X-ray (AP and Lateral)
Tidsramme: Follow Up Visits up to 1 Year
Subjectively evaluate fracture healing
Follow Up Visits up to 1 Year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Utah

Samarbejdspartnere

William Beaumont Army Medical Center

Efterforskere

  • Ledende efterforsker: David Rothberg, MD, Orthopedic Surgery

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. januar 2013

Primær færdiggørelse (Faktiske)

10. juli 2017

Studieafslutning (Faktiske)

10. juli 2017

Datoer for studieregistrering

Først indsendt

18. juni 2014

Først indsendt, der opfyldte QC-kriterier

20. juni 2014

Først opslået (Skøn)

23. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. oktober 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 58956

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 Frakturer med nedre ekstremitet

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Argentina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner