Insole Sensor to Determine Optimal Limb Loading
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Utah
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Salt Lake City, Utah, États-Unis, 84108
- University of Utah
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Patient Activity Measure (PAM-13) Questionnaire
Délai: Follow Up Visits up to 1-Year
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A subjective evaluation of perceived compliance with physician instruction
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Follow Up Visits up to 1-Year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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X-ray (AP and Lateral)
Délai: Follow Up Visits up to 1 Year
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Subjectively evaluate fracture healing
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Follow Up Visits up to 1 Year
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: David Rothberg, MD, Orthopedic Surgery
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 58956
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