Gait Rehabilitation for Amputation
(GEM Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Error-augmentation gait training for gait rehabilitation in individuals with amputation?
Research shows that gait training, including error-augmentation techniques, can improve walking patterns and balance in people with lower limb amputations. Studies have found that both overground and treadmill-based gait training, especially when combined with feedback and support, are effective in enhancing gait symmetry and overall walking ability.12345
Is gait rehabilitation for amputation generally safe for humans?
Gait rehabilitation, including error-manipulation and robotic-assisted training, is generally safe but can cause some discomfort or injuries like skin irritation, musculoskeletal issues, and blood pressure changes. These risks are often related to the equipment used, such as exoskeletons or stationary gait robots, and can be managed with proper safety measures.23567
How does error-augmentation gait training differ from other treatments for gait rehabilitation after amputation?
Error-augmentation gait training is unique because it intentionally introduces errors in movement to help patients learn to correct their gait, which can improve step length symmetry and other health outcomes. This approach contrasts with traditional methods that focus on error reduction, and it has shown promise in improving force symmetry during treadmill training, although more research is needed to enhance its effectiveness for overground walking.23589
What is the purpose of this trial?
The population of older Veterans with non-traumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for Veterans with non-traumatic lower limb amputation. Additional this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for Veterans with non-traumatic amputation through gait training programs based in motor learning principles, resulting in improved gait symmetry and lower incidence of long-term disability after non-traumatic lower limb amputation.
Research Team
Cory L. Christiansen, PhD
Principal Investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
Eligibility Criteria
This trial is for older Veterans with diabetes or peripheral artery disease who have had a non-traumatic amputation below the knee. They should be able to walk without help and have had their amputation between 6 months and 10 years ago. Those with traumatic or cancer-related amputations, unstable heart conditions, infections, or active cancer treatment cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 4-week, 8 session gait training program using error-manipulation techniques
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of gait symmetry and secondary measures
Treatment Details
Interventions
- Error-augmentation gait training
- Error-correction gait training
- Supervised walking
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor