NCT04047030

The Mobility Toolkit: Electronically Augmented Assessment of Functional Recovery Following Lower-extremity Trauma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 244 (actual)
• Sponsor: Major Extremity Trauma Research Consortium · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: —

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.

Conditions

• Gait

Interventions

Type	Name	Description
OTHER	None- Observational Study	No Intervention

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-12-01
• Completion: 2024-08-31
• First posted: 2019-08-06
• Last updated: 2025-10-06

Locations

10 sites across 1 country: United States