GaitMBTKNCT04047030
The Mobility Toolkit: Electronically Augmented Assessment of Functional Recovery Following Lower-extremity Trauma
An observational study of Gait, run by Major Extremity Trauma Research Consortium at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gait
- What is being tested?
- None- Observational Study
- How many people
- 244 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Jan 2019to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
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.
Who may be able to join
- 18-60 years of age
- Open or closed fractures of the tibial plateau, pilon, ankle or calcaneus requiring surgical fixation.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Mission Hospital
Asheville, North Carolina, 28801
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Carolinas Medical Center
Charlotte, North Carolina, 28204
Womack Army Medical Center at Ft. Bragg
Fort Bragg, North Carolina, 28100
University of Texas Health Science Center - Houston
Houston, Texas, 77030
University of Kentucky
Lexington, Kentucky, 40506
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
San Antonio Military Medical Center (SAMMC)
San Antonio, Texas, 78234
Barnes Jewish Hospital
St Louis, Missouri, 63110
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.
Read the 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
- Being tested
- None- Observational Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None- Observational StudyOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Injured Cohort | Approximately 300 participants treated for a fracture of the tibial plateau, pilon, ankle or calcaneus will be enrolled from METRC civilian trauma centers and military treatment facilities over an 18 month period. Participating centers treat large numbers of severe orthopaedic injuries and have a proven track record for successfully recruiting and retaining participants in prospective studies in orthopaedic trauma. Participants will be enrolled following definitive treatment of their injury. Receives: Other: None- Observational Study | |
| Non-Injured Volunteers | Non-injured adults of similar age and gender distribution will be enrolled at two participating centers (Carolinas Medical Center and Womack Military Medical Center). The sample of non-injured volunteers will exclude individuals with history of lower extremity injury, vascular disease, or who require use of ambulatory aides to walk. Receives: Other: None- Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of use of the Mobility Toolkit during clinic
Feasibility will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits.
Measured: 12 months
Satisfaction of the Mobility Toolkit
Satisfaction will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits.
Measured: 12 months
Gait Quality assessed with Mobility Tooklkit
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.
Measured: 12 months
Gait Quality assessed by performance tests
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.
Measured: Change in gate from measured at 3, 6 & 12 months
Physical Function
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.
Measured: Change in physical function measured at 3, 6, & 12 months
Pain Score
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.
Measured: Change in pain score measured at 3, 6, & 12 months
Number of patient complications resulting from injury
Injury related complications such as infection, non-union, and hardware failure will be captured prospectively the year following treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Jan 2019
- Primary completion1 Dec 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Sims, MD, Principal investigator, Carolinas Medical CenterLisa Reider, PhD, Principal investigator, JHSPH/METRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047030
- Sponsor's protocol ID
- W81XWH-18-1-0815
- Acronym
- MBTK
- Status last verified
- Sep 2025
- First submitted
- 26 Jul 2019
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing beyond manuscripts and scientific presentations will be processed through the METRC website in the short term. Currently, a standard form will be available for researchers outside METRC to request access to final data generated from METRC studies. These requests will be transmitted to the METRC Coordinating Center for initial review to make sure the relevant materials are provided in support of the request. METRC is committed to making data as widely available as possible while safeguarding the privacy of study participants and protecting the intellectual property of the Consortium. Data will only be made available after it is completely stripped of identifiable information such as dates, geographic locators, and any other event information which is sufficiently rare as to make it possible to deduce the identity of an individual participant. When necessary for complete de-identification, data may be grouped.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mobility Toolkit: Electronically Augmented Assessment of Functional Recovery Following Lower-extremity Trauma
- ClinicalTrials.gov ID
- NCT04047030
- Acronym / sponsor ID
- MBTK / W81XWH-18-1-0815
- Conditions
- Gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injured Cohort | – | Other: None- Observational StudyApproximately 300 participants treated for a fracture of the tibial plateau, pilon, ankle or calcaneus will be enrolled from METRC civilian trauma centers and military treatment facilities over an 18 month period. Participating centers treat large numbers of severe orthopaedic injuries and have a proven track record for successfully recruiting and retaining participants in prospective studies in orthopaedic trauma. Participants will be enrolled following definitive treatment of their injury. |
| Non-Injured Volunteers | – | Other: None- Observational StudyNon-injured adults of similar age and gender distribution will be enrolled at two participating centers (Carolinas Medical Center and Womack Military Medical Center). The sample of non-injured volunteers will exclude individuals with history of lower extremity injury, vascular disease, or who require use of ambulatory aides to walk. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 18-60 years of age
- Open or closed fractures of the tibial plateau, pilon, ankle or calcaneus requiring surgical fixation.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None- Observational StudyNo Intervention | Other | Injured Cohort, Non-Injured Volunteers |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: Yes. Data sharing beyond manuscripts and scientific presentations will be processed through the METRC website in the short term. Currently, a standard form will be available for researchers outside METRC to request access to final data generated from METRC studies. These requests will be transmitted to the METRC Coordinating Center for initial review to make sure the relevant materials are provided in support of the request. METRC is committed to making data as widely available as possible while safeguarding the privacy of study participants and protecting the intellectual property of the Consortium. Data will only be made available after it is completely stripped of identifiable information such as dates, geographic locators, and any other event information which is sufficiently rare as to make it possible to deduce the identity of an individual participant. When necessary for complete de-identification, data may be grouped.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Sims, MD principal investigator
Carolinas Medical Center
Lisa Reider, PhD principal investigator
JHSPH/METRC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait, run by Major Extremity Trauma Research Consortium at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of use of the Mobility Toolkit during clinic (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.