Clinical trial NCT04047030: The Mobility Toolkit: Electronically Augmented Assessment of Functional Recovery Following Lower-extremity Trauma
Official title: The Mobility Toolkit: Electronically Augmented Assessment of Functional Recovery Following Lower-extremity Trauma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gait
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults ages 18-60 surgically treated for a fracture of the tibial plateau, pilon, ankle, or calcaneus at one of 10 participating centers. Patients meeting the inclusion and exclusion criteria will approached for enrollment in to the study.

Brief summary: The study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus.

Detailed description: The study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus. All participating centers will undergo training to implement the Mobility Toolkit (MTK). Research Staff will facilitate a series of performance tests while participants wear the MTK device. MTK assessment will also be conducted on 150 non-injured adults matched to the injured cohort on age and gender. These individuals will be enrolled and assessed once at two participating centers. Study flow and data capture are summarized in the figure on the next page.

Eligibility criteria: Inclusion Criteria:

1. 18-60 years of age
2. Open or closed fractures of the tibial plateau, pilon, ankle or calcaneus requiring surgical fixation.

Exclusion Criteria:

1. Gustilo type IIIB or IIIC injuries
2. No other surgically or non-surgically treated injuries that impact gait (e.g. upper extremity injury proximal to the elbow; spinal cord injury; contralateral or ipsilateral fractures).
3. Neurologic impairment or deficit that impairs gait
4. Prior injuries or conditions that alter gait (e.g. severe osteoarthritis)
5. Severe problems with maintaining follow-up (e.g. participants who are prisoners, who are intellectually challenged without adequate family support, or have documented psychiatric disorders).
6. Unable to provide informed consent in English or Spanish.

Primary outcomes:
measure: Ease of use of the Mobility Toolkit during clinic
timeFrame: 12 months
measure: Satisfaction of the Mobility Toolkit
timeFrame: 12 months
measure: Gait Quality assessed with Mobility Tooklkit
timeFrame: 12 months
measure: Gait Quality assessed by performance tests
timeFrame: Change in gate from measured at 3, 6 & 12 months
measure: Physical Function
timeFrame: Change in physical function measured at 3, 6, & 12 months
measure: Pain Score
timeFrame: Change in pain score measured at 3, 6, & 12 months
measure: Number of patient complications resulting from injury
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland R Adams Cowley Shock Trauma Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Fort Bragg
country: United States
facility: Womack Army Medical Center at Ft. Bragg
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center - Houston
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center (SAMMC)
state: Texas
Study officials:
affiliation: Carolinas Medical Center
name: Stephen Sims, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: JHSPH/METRC
name: Lisa Reider, PhD
role: PRINCIPAL_INVESTIGATOR
References: