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?

This trial aims to help Veterans with non-traumatic lower limb amputations improve their walking patterns. It tests two types of gait training programs to correct uneven steps and enhance overall mobility. Participants will either undergo error-augmentation gait training, which uses treadmills to adjust step length, or error-correction gait training, which uses a metronome to guide walking rhythm. Veterans who have had a non-traumatic lower leg amputation due to diabetes or peripheral artery disease and can walk without assistance might be suitable candidates. The goal is to enhance walking symmetry and reduce long-term issues like pain and skin problems. As an unphased trial, this study offers Veterans the opportunity to contribute to innovative research that could improve mobility and quality of life for others with similar conditions.

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 prior data suggests that these gait training programs are safe for Veterans with non-traumatic lower limb amputation?

A previous study found that a special type of walking training called error-augmentation was safe and practical for helping people with non-traumatic lower limb amputations improve their walking. The study showed that even one session could change walking patterns without causing harm. Another study examined error-correction walking training, which also aims to safely improve walking patterns. Both types of training are part of a larger effort to help Veterans with amputations walk better by correcting uneven steps. These studies reported no serious side effects, indicating that these training methods are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these gait rehabilitation techniques for amputees because they offer innovative approaches to improving walking patterns. Error-augmentation gait training uses a split-belt treadmill to exaggerate step asymmetry, encouraging the body to self-correct and achieve a more balanced gait. On the other hand, error-correction training employs an auditory metronome to guide and overcorrect stance time asymmetry, providing real-time feedback to help retrain the brain's perception of balance. These methods differ from standard physical therapy by actively manipulating walking errors to promote faster adaptation and learning, potentially leading to more efficient rehabilitation outcomes for those with limb loss.

What evidence suggests that this trial's gait training programs could be effective for improving gait symmetry in Veterans with non-traumatic lower limb amputation?

Research has shown that error-augmentation gait training, a treatment in this trial, can improve walking balance in people with below-knee amputations. Conducted on a special treadmill with two moving belts, this training is both practical and safe. It helps even out steps, leading to better walking patterns.

Error-correction gait training, another treatment option in this trial, also shows promise in enhancing step balance. This method uses a rhythmic sound to correct step timing and demonstrated potential in initial tests. Both training types in this trial aim to enhance walking ability and reduce long-term disability for those with lower limb amputations. ^{1 2 6 7 8}

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

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]

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]

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]

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]

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]

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]

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6880787/

Error-Augmentation Gait Training to Improve ... A single-session of EGT is a feasible and safe intervention to modify gait asymmetry in patients with non-traumatic transtibial amputation.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03995238

NCT03995238 | Optimizing Gait Rehabilitation for Veterans ... As a means of improving gait symmetry, this study aims to determine the efficacy of error-manipulation gait training using two approaches (error-augmentation ...

3. journals.lww.com journals.lww.com/10.1097/PXR.0000000000000181

Feasibility of repeated session error-augmentation gait... The objective was to evaluate the feasibility and efficacy of an eight-session, treadmill-based error-augmentation gait training (EAT) protocol to improve ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34379777/

Error-Manipulation Gait Training for Veterans With ... Objective: he purpose of this study will be to determine the efficacy of error-manipulation gait training (error-augmentation or error- ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0966636212002421

Effect of robotic performance-based error-augmentation ... The current study sought to identify which of these training strategies promote better short-term modification of a typical gait pattern in healthy individuals.

6. journals.lww.com journals.lww.com/00006479-201943040-00008

Error-augmentation gait training to improve gait symmetry... Error-augmentation gait training to improve gait symmetry in patients with non-traumatic lower limb amputation. A proof-of-concept study.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8639646/

Error-manipulation Gait Training for Veterans with Non ... This study protocol focuses on an understudied area of rehabilitation for patients with non-traumatic unilateral TTA who have high levels of spatiotemporal gait ...

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/383076

Optimizing Gait Rehabilitation for Veterans With Non ... This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait ...