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Behavioural Intervention

AlterG anti-gravity treadmill for Distal Tibia Fractures (AlterG Trial)

N/A
Waitlist Available
Led By Daniel Stinner, MD
Research Sponsored by Major Extremity Trauma Research Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month following study injury
Awards & highlights

Summary

This study is evaluating whether a treadmill which reduces the weight of the body may help people recover from a broken ankle.

Eligible Conditions
  • Distal Femur Fracture
  • Distal Tibia Fractures
  • Pilon Fracture
  • Tibial Plateau Fracture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month following study injury
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month following study injury for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ankle Osteoarthritis Score (AOS)
Knee
Secondary outcome measures
Complications
Fracture healing
Patient Outcomes Measurement Information Systems (PROMIS) Physical Function
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early Advanced Weight Bearing (EAWB)Experimental Treatment1 Intervention
The Early Advanced Weight Bearing (EAWB) group will receive early weight-bearing treatment using the antigravity AlterG treadmill. These sessions will begin 14-28 days following definitive fixation and last for a total of 10 weeks
Group II: Standard of CareActive Control1 Intervention
The standard of care group will remain non-weight bearing for 10-12 weeks following definitive fixation and receive physical therapy in accordance with standard practice at the treating center.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
875 Previous Clinical Trials
329,905 Total Patients Enrolled
Major Extremity Trauma Research ConsortiumLead Sponsor
31 Previous Clinical Trials
27,375 Total Patients Enrolled
Daniel Stinner, MDPrincipal InvestigatorVanderbilt University Medical Center
~13 spots leftby Jul 2025