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Behavioural Intervention
Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries (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
No Placebo-Only Group
Summary
This trial compares a special treadmill that reduces body weight impact with regular physical therapy. It targets adults with lower leg and joint injuries. The treadmill helps by lifting some of the body weight, making it easier to exercise without causing more pain or injury. This method is commonly used in rehabilitation to improve walking, balance, and muscle strength.
Eligible Conditions
- Broken knee
- Distal Femur Fracture
- Pilon Fracture
- Distal Tibia Fractures
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month following study injury
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month following study injury
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ankle Osteoarthritis Score (AOS)
Knee
Secondary study objectives
Complications
Fracture healing
Patient Outcomes Measurement Information Systems (PROMIS) Physical Function
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
916 Previous Clinical Trials
334,636 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