Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries

(AlterG Trial)

Recruiting at 9 trial locations

Overseen By Craig Remenapp, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Major Extremity Trauma Research Consortium

Disqualifiers: Severe brain injury, Stroke, Heart disease, Pregnancy, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10-12 weeks

81 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the AlterG anti-gravity treadmill treatment?

Research shows that the AlterG anti-gravity treadmill is safe and feasible for rehabilitation after knee surgery, with improvements in pain and quality of life. It also helps reduce pain during exercise for people with lower limb osteoarthritis, suggesting it could be a useful therapy for these conditions. ^{1 2 3 4 5}

Is the AlterG Anti-Gravity Treadmill safe for use in humans?

The AlterG Anti-Gravity Treadmill has been shown to be safe in a study involving patients undergoing rehabilitation after total knee replacement, with no adverse events reported during the trial. ^{1 4 6 7 8}

How does the AlterG anti-gravity treadmill treatment differ from other treatments for lower limb osteoarthritis?

The AlterG anti-gravity treadmill is unique because it allows patients to exercise with reduced weight on their lower limbs, which can alleviate pain during exercise. This makes it a novel option for those with lower limb osteoarthritis, as it enables aerobic exercise without the increased pain that might occur with regular walking. ^{2 9 10 11 12}

What is the purpose of this trial?

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.

Research Team

Daniel Stinner, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive early weight-bearing treatment using the antigravity AlterG treadmill or standard of care physical therapy

10-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• AlterG anti-gravity treadmill

Participant Groups

Group I: Early Advanced Weight Bearing (EAWB) Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

Major Extremity Trauma Research Consortium

Lead Sponsor

Trials

32

Recruited

27,400+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of an Anti-Gravity Treadmill for Early Postoperative Rehabilitation After Total Knee Replacement: A Pilot Study to Determine Safety and Feasibility. [2017]

2. Japan pubmed.ncbi.nlm.nih.gov

Anti-gravity treadmill can promote aerobic exercise for lower limb osteoarthritis patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The effect of anti-gravity treadmill training for knee osteoarthritis rehabilitation on joint pain, gait, and EMG: Case report. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effect of speed and gradient on plantar force when running on an AlterG® treadmill. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Lower limb EMG activation during reduced gravity running on an incline. Speed matters more than hills irrespective of indicated bodyweight. [2021]

6. Japan pubmed.ncbi.nlm.nih.gov

Effects of graded load of artificial gravity on cardiovascular functions in humans. [2011]

7. Belgium pubmed.ncbi.nlm.nih.gov

The effect of anti-gravity training after meniscal or chondral injury in the knee. A systematic review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Exercise Responses to Gravity-Independent Flywheel Aerobic and Resistance Training. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

The "Space Cycle" Self Powered Human Centrifuge: a proposed countermeasure for prolonged human spaceflight. [2005]

10. England pubmed.ncbi.nlm.nih.gov

Pedalling in space as a countermeasure to microgravity deconditioning. [2013]

11. China pubmed.ncbi.nlm.nih.gov

[Biomedical problems of artificial gravity: overview and challenge]. [2006]

12. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Treadmill with Vibration Isolation and Stabilization (TVIS) for use on the International Space Station. [2019]