Gait Rehabilitation for Amputation

(GEM Trial)

Recruiting at 1 trial location

Overseen By Ryan Stephenson, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Unstable heart condition, Cancer, others

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

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

54 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{2 3 4 6 7}

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. ^{2 3 4 8 9}

Who Is on the Research Team?

Cory L. Christiansen, PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I do not have an unstable heart condition.

I am currently receiving treatment for cancer.

I currently have a serious infection.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Error-correction training Experimental Treatment 1 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 training Experimental Treatment 1 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 waking Active Control 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Strength training, EMG biofeedback, and functional electrical stimulation have strong or moderate evidence supporting their effectiveness as adjunct therapies in gait retraining for stroke rehabilitation, based on a review of 48 studies.

In contrast, techniques like ankle-foot orthosis, treadmill training, and partial body-weight support show limited or conflicting evidence regarding their efficacy in improving gait after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait retraining post stroke. Teasell, RW., Bhogal, SK., Foley, NC., et al.[2016]

This study will evaluate the effectiveness of two types of gait training—error-augmentation and error-correction—on improving step length symmetry in 54 veterans aged 50 to 85 with unilateral transtibial amputation, using a randomized controlled trial design.

The primary outcome is step length symmetry, assessed through an asymmetry index, with secondary outcomes including joint work, walking performance, daily step count, and perceived disability, aiming to enhance rehabilitation strategies for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Error-Manipulation Gait Training for Veterans With Nontraumatic Lower Limb Amputation: A Randomized Controlled Trial Protocol. Kline, PW., So, N., Fields, T., et al.[2022]

A systematic review of 50 studies involving 985 subjects revealed that adverse events (AEs) occurred in 18 studies, with over 169 device-related AEs reported, primarily soft tissue injuries and musculoskeletal issues, particularly in end-effector and exoskeleton devices.

The most common risks associated with stationary robot-assisted gait training include excessive pressure and shear at the interface between the device and the user, as well as misalignments that increase forces on the musculoskeletal system, highlighting the need for improved reporting and safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. Bessler, J., Prange-Lasonder, GB., Schulte, RV., et al.[2021]

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

A 3-week virtual reality-based gait training program significantly improved biomechanical performance in a 24-year-old man with a transfemoral amputation, enhancing hip, pelvis, and trunk motion during walking.

The training also led to a notable decrease in oxygen consumption by up to 23%, indicating improved efficiency in walking compared to previous interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait training with virtual reality-based real-time feedback: improving gait performance following transfemoral amputation. Darter, BJ., Wilken, JM.[2022]

Rhythmic stimulation, whether through vibrotactile or auditory methods, significantly improves stance time symmetry ratio (STSR) in healthy adults with induced gait asymmetry, suggesting its potential for gait rehabilitation.

Both types of rhythmic stimulation were equally effective in enhancing gait parameters, indicating that either method could be used to aid individuals with mobility impairments in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Short-Term Effects of Rhythmic Vibrotactile and Auditory Biofeedback on the Gait of Individuals After Weight-Induced Asymmetry. Michelini, A., Sivasambu, H., Andrysek, J.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Effect of robotic performance-based error-augmentation versus error-reduction training on the gait of healthy individuals. [2021]

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

Gait Training Interventions for Lower Extremity Amputees: A Systematic Literature Review. [2020]

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

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]

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

Gait retraining post stroke. [2016]

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

Error-Manipulation Gait Training for Veterans With Nontraumatic Lower Limb Amputation: A Randomized Controlled Trial Protocol. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. [2020]

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

Gait training with virtual reality-based real-time feedback: improving gait performance following transfemoral amputation. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

The Short-Term Effects of Rhythmic Vibrotactile and Auditory Biofeedback on the Gait of Individuals After Weight-Induced Asymmetry. [2023]