54 Participants Needed

Gait Rehabilitation for Amputation

(GEM Trial)

Recruiting at 1 trial location
CL
NL
RS
Overseen ByRyan Stephenson, DO
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

CL

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

I can walk on my own without any help from devices.
It has been 6 months to 10 years since my amputation.
My walking step lengths are uneven.
See 2 more

Exclusion Criteria

I do not have an unstable heart condition.
I am currently receiving treatment for cancer.
I currently have a serious infection.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week, 8 session gait training program using error-manipulation techniques

4 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of gait symmetry and secondary measures

12 weeks

Treatment Details

Interventions

  • Error-augmentation gait training
  • Error-correction gait training
  • Supervised walking
Trial Overview The study tests two gait training programs designed to improve walking symmetry in Veterans after lower limb loss: error-augmentation and error-correction training, plus supervised walking. It aims to see if these can reduce disability and improve skin health on the remaining limb.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Error-correction trainingExperimental Treatment1 Intervention
A 4-week, 8 session, treadmill-based gait training program, with error-correction of step asymmetry delivered with an auditory metronome signal while walking on a treadmill. During each training block, the metronome will be set to overcorrect stance time asymmetry through use of asymmetrical metronome tones, 2:1 ratio.
Group II: Error-augmentation trainingExperimental Treatment1 Intervention
A 4-week, 8 session, treadmill-based gait training program, with error-augmentation of step asymmetry delivered on a split-belt treadmill. Each training session will adhere to the same schedule. During the training blocks on the treadmill, the belt under the limb with the shorter step length will be set at 3/4 of the pre-intervention over-ground self-selected walking speed while the belt under the limb with the longer step length will be set to 1/2 of the fast belt speed (2:1 ratio between belts).
Group III: Supervised wakingActive Control1 Intervention
A 4-week, 8 session, treadmill-based supervised walking program. The active comparator group will participate in a supervised treadmill walking program of the same frequency and duration, to the two experimental groups.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Findings from Research

In a study involving 20 healthy individuals, training with a robotic exoskeleton using an error-augmentation strategy led to better retention of an improved ankle path during walking compared to an error-reduction strategy.
Both training methods initially improved ankle positioning, but only the error-augmentation group maintained these improvements after the robotic assistance was removed, suggesting it may be more effective for long-term motor learning.
Effect of robotic performance-based error-augmentation versus error-reduction training on the gait of healthy individuals.Kao, PC., Srivastava, S., Agrawal, SK., et al.[2021]
Gait training interventions, both overground and treadmill-based, are essential for lower extremity amputees to address gait asymmetries and improve overall biomechanics, as supported by a systematic review of 18 studies.
Overground training combined with various feedback methods and treadmill training with visual feedback or body weight support were found to significantly enhance gait performance, including improvements in walking distance and movement strategies.
Gait Training Interventions for Lower Extremity Amputees: A Systematic Literature Review.Highsmith, MJ., Andrews, CR., Millman, C., et al.[2020]
Training with a robotic Tethered Pelvic Assist Device using both error reduction and error augmentation models improved force symmetry during treadmill training in two stroke survivors, indicating the device's feasibility for rehabilitation.
While both training paradigms were tolerated well, the improvements in force symmetry did not fully translate to overground gait, suggesting a need for further research to enhance the effectiveness of training for real-world walking.
Exploration of Two Training Paradigms Using Forced Induced Weight Shifting With the Tethered Pelvic Assist Device to Reduce Asymmetry in Individuals After Stroke: Case Reports.Bishop, L., Khan, M., Martelli, D., et al.[2017]

References

Effect of robotic performance-based error-augmentation versus error-reduction training on the gait of healthy individuals. [2021]
Gait Training Interventions for Lower Extremity Amputees: A Systematic Literature Review. [2020]
Exploration of Two Training Paradigms Using Forced Induced Weight Shifting With the Tethered Pelvic Assist Device to Reduce Asymmetry in Individuals After Stroke: Case Reports. [2017]
Gait retraining post stroke. [2016]
Error-Manipulation Gait Training for Veterans With Nontraumatic Lower Limb Amputation: A Randomized Controlled Trial Protocol. [2022]
Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]
Risk management and regulations for lower limb medical exoskeletons: a review. [2020]
Gait training with virtual reality-based real-time feedback: improving gait performance following transfemoral amputation. [2022]
The Short-Term Effects of Rhythmic Vibrotactile and Auditory Biofeedback on the Gait of Individuals After Weight-Induced Asymmetry. [2023]
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