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Completed

NCT Number: NCT04047030

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

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.

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Key information

Conditions

Gait

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kentucky, Lexington, Kentucky, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Gustilo type IIIB or IIIC injuries
  • 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).
  • Neurologic impairment or deficit that impairs gait
  • Prior injuries or conditions that alter gait (e.g. severe osteoarthritis)
  • 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).
  • Unable to provide informed consent in English or Spanish.

Treatment and study plan

None- observational study

Other

No Intervention

Primary outcomes

  1. Ease of use of the Mobility Toolkit during clinic

    Time frame: 12 months

    Feasibility will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits.

  2. Satisfaction of the Mobility Toolkit

    Time frame: 12 months

    Satisfaction will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits.

  3. Gait Quality assessed with Mobility Tooklkit

    Time frame: 12 months

    Gait Quality will be measured using the MTK to assess gait parameters such as lift acceleration, step time asymmetry, and peak-to-peak upper body pitch and roll.

  4. Gait Quality assessed by performance tests

    Time frame: Change in gate from measured at 3, 6 & 12 months

    Gait will be assessed while completing three performance tests: 10 meter walk, sit to stand, and timed up and go (TUG) Injured participants will be assessed at time of first weight bearing, and at clinic visits 3, 6 and 12 months following definitive treatment.

  5. Physical Function

    Time frame: Change in physical function measured at 3, 6, & 12 months

    Patient Reported Function will be assessed using the physical function item banks from the Patient Reported Outcomes Measurement Information System (PROMIS). Injured participants will be assessed at baseline and at each follow-up visit.

  6. Pain Score

    Time frame: Change in pain score measured at 3, 6, & 12 months

    Patient Reported Pain will be assessed using the pain interference item banks from the Patient Reported Outcomes Measurement Information System (PROMIS). Injured participants will be assessed at baseline and at each follow-up visit.

  7. Number of patient complications resulting from injury

    Time frame: 12 months

    Injury related complications such as infection, non-union, and hardware failure will be captured prospectively the year following treatment.

Sponsors and collaborators

Lead sponsor

Major Extremity Trauma Research Consortium

Other

Registry information

Acronym: MBTK

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Aug 6, 2019
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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