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Purpose

The overall objective of this study is to compare outcomes following early advanced weight bearing (EAWB) using the AlterG antigravity treadmill versus standard of care physical therapy for adult patients with lower extremity periarticular injuries.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Ages 18-55
  • Closed or Open (Gustilo Type I, II or IIIA) fractures: Distal femur (AO/OTA 33B, 33C), tibial plateau (AO/OTA 41B, 41C), or Distal tibia/pilon (AO/OTA 43B, 43C)
  • Definitively treated with a plate
  • Ambulatory prior to injury
  • Able to participate in rehab starting 28 days after definitive fixation
  • Meets AlterG requirements (4'8- 6'4; 85-400lbs)

Exclusion Criteria

  • Medical or psychological disease that would preclude safe functional testing (e.g., severe traumatic brain injury, stroke, heart disease, etc.)
  • Prior joint trauma or disease of the operative extremity that resulted in pain, stiffness, or other limitation to mobility
  • Injury to the contra-lateral limb, upper extremities or axial skeleton that would influence single limb weight-bearing or use of an assistive device
  • Pregnancy
  • Unable to speak English
  • Severe problems with maintaining follow-up (e.g. patients who are prisoners, homeless at the time of injury, who are intellectually challenged without adequate family support, or have documented psychiatric disorders).
  • Unable to provide informed consent.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Standard of Care
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.
Experimental
Early Advanced Weight Bearing (EAWB)
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
  • Other: AlterG anti-gravity treadmill
    The AlterG treadmill is an FDA approved device that allows patients to perform early partial weight bearing exercises in a tightly controlled and safe environment

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40506
Contact:
Paul Stringer, BS
paul.stringer@uky.edu

More Details

NCT ID
NCT03562364
Status
Recruiting
Sponsor
Major Extremity Trauma Research Consortium

Study Contact

Lisa Reider, PhD
4105023962
lsemani1@jhu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.