Transtibial AmputationGEMNCT03995238
Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation
A study testing Error-augmentation gait training, Error-correction gait training and Supervised walking in people with Transtibial Amputation and Peripheral Artery Disease, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Transtibial Amputation, Peripheral Artery Disease, Diabetes Mellitus
- What is being tested?
- Error-augmentation gait training, Error-correction gait training and Supervised walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Oct 2019to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral, non-traumatic, transtibial amputation
- Diabetes mellitus and/or peripheral artery disease
- Able to ambulate in the community without assistive device
- Step length asymmetry during walking (>1.0 asymmetry index.)
- 6 months since amputation
Who cannot join
- Unstable heart condition
- Including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis
- Acute systemic infection
- Active cancer treatment
- Traumatic or cancer related amputation etiology
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Ryan Stephenson, DO, 303-399-8020, ryan.stephenson@va.gov
Thomas Fields, DPT, (720) 723-3372, thomas.fields@va.gov
- Recruiting
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249
John Hermanson, MD, john.hermanson@va.gov
Benjamin Darter, DPT, benjamin.darter@va.gov
About this study
Official title: Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation
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.
Read the detailed description
The focus of this study is to improve walking symmetry in order to optimize walking ability and reduce disability for Veterans with non-traumatic lower limb amputation (LLA). Over 80% of current LLAs are non-traumatic, resulting from complications of pathologies, such as diabetes mellitus and peripheral artery disease. Despite current declines in total amputation rate among Veterans, the population with non-traumatic LLA is growing. For example, from 2000 to 2004 the relative amputation rate decreased by 34%. However, due to an increase in the number of Veterans with diabetes during the same period, the population of Veterans with diabetes and initial LLA increased by 23%. Following LLA, excessive gait asymmetry is common. Asymmetric gait characteristics are of critical importance as excessive asymmetry may increase the severity of disability experienced by people with non-traumatic LLA and contribute to secondary pain conditions (low back pain and osteoarthritis), poor gait efficiency, declines in physical performance, and compromised skin integrity of the residual limb. Compared to individuals with traumatic LLA, the poor gait performance of those with non-traumatic LLA is further compounded by older age, lower premorbid function, presence of comorbidities, frequent wound development, and delayed healing in the residual limb. While improving gait symmetry is a goal of conventional prosthetic rehabilitation, persistence of gait asymmetry for years after LLA highlights the ineffectiveness of current rehabilitation practices in achieving this goal. As a means of improving gait symmetry, this study aims to determine the efficacy of error-manipulation gait training using two approaches (error-augmentation and error-correction) compared to current standard-of-care in a three-arm randomized controlled trial. Error-manipulation gait training intervention will be delivered in eight training sessions (2x/week, 4 weeks) with 54 Veterans (18 per intervention group, 18 in control group) who have non-traumatic, unilateral, transtibial LLA. It is unclear which, if either, form of error-manipulation gait training is efficacious for improving persistent gait symmetry in Veterans with non-traumatic LLA. Error-augmentation gait training is a promising and novel intervention that involves exaggerating an existing movement error to force the neuromuscular system to correct the error. While this form of gait training improved gait symmetry in small studies of individuals with chronic stroke or traumatic amputation, it has yet to be evaluated in older Veterans with non-traumatic LLA. In contrast, error-correction training involves reducing movement errors by overcorrecting for asymmetry. Both error-augmentation and error-correction gait training are based upon motor learning principles of distributed practice, task specificity, and feedback. Each of these error-manipulation interventions have potential advantages over traditional gait training following LLA which involves repeated bouts of walking with minimal feedback on movement quality and is often unsupervised. Therefore, the primary aim of this study is to determine the efficacy of error-manipulation gait training to improve gait symmetry. A secondary aim is to evaluate signals of efficacy for improved secondary measures of physical function. Lastly, this study will explore changes to residual limb skin health and prosthesis socket fit following error-manipulation gait training. The unique use of motor learning principles in error-manipulation gait training to improve gait symmetry addresses the problem of chronic gait asymmetry following non-traumatic LLA. The results of this study will advance rehabilitation knowledge and provide necessary evidence for the clinical translation of gait training protocols based in motor learning principles for the at-risk population of Veterans with non-traumatic LLA.
- Being tested
- Error-augmentation gait training, Error-correction gait training, Supervised walking
- Keywords
- Amputation, Rehabilitation, Gait Training, Diabetes, Peripheral Artery Disease
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Error-augmentation gait trainingBehavioural
Split-belt treadmill training to enhance between-limb asymmetry during treadmill walking, which is intended to force compensation and correction of step asymmetry during treadmill walking. The error-augmentation gait training program is delivered in 8 sessions over 4 weeks.
Error-correction gait trainingBehavioural
Metronome will be set to cue participants to overcorrect between-limb step asymmetry during treadmill walking, through use of asymmetrical metronome tones in a 2:1 ratio. The error-correction gait training program is delivered in 8 sessions over 4 weeks.
Supervised walkingBehavioural
An active comparator intervention, in which a supervised treadmill walking program is delivered without attempt to correct step asymmetry. The supervised walking program is delivered in 8 sessions over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Error-augmentation training | Experimental | 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). Receives: Behavioral: Error-augmentation gait training |
| Error-correction training | Experimental | 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. Receives: Behavioral: Error-correction gait training |
| Supervised waking | Active comparator | 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. Receives: Behavioral: Supervised walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Length Symmetry
Measurement of step length symmetry by overground walking on GAITRite mat and kinetic and kinematic measurements using 3-D motion capture system.
Measured: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.
Secondary outcomes (3)
Six-minute walk test
Physical function test measuring the total distance walked in a span of six minutes.
Measured: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.
Free-living daily step count
Accelerometer-based measurement of free-living daily step count
Measured: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.
World Health Organization Disability Assessment Scale 2.0
Self-reported assessment of disability using a scale from 0 to 100, with 0 representing no disability, and 100 representing full disability.
Measured: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start9 Oct 2019
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transtibial AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial; Three groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cory L. Christiansen, PhD, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995238
- Sponsor's protocol ID
- A3237-R
- Acronym
- GEM
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be made available at time of study completion, per VA recommendations and approval.
Publications
B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
PubMed 37276273Kline PW, So N, Fields T, Juarez-Colunga E, Christiansen CL. Error-Manipulation Gait Training for Veterans With Nontraumatic Lower Limb Amputation: A Randomized Controlled Trial Protocol. Phys Ther. 2021 Nov 1;101(11):pzab192. doi: 10.1093/ptj/pzab192.
PubMed 34379777
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT03995238
- Acronym / sponsor ID
- GEM / A3237-R
- Keywords
- Amputation, Rehabilitation, Gait Training, Diabetes, Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The focus of this study is to improve walking symmetry in order to optimize walking ability and reduce disability for Veterans with non-traumatic lower limb amputation (LLA). Over 80% of current LLAs are non-traumatic, resulting from complications of pathologies, such as diabetes mellitus and peripheral artery disease. Despite current declines in total amputation rate among Veterans, the population with non-traumatic LLA is growing. For example, from 2000 to 2004 the relative amputation rate decreased by 34%. However, due to an increase in the number of Veterans with diabetes during the same period, the population of Veterans with diabetes and initial LLA increased by 23%. Following LLA, excessive gait asymmetry is common. Asymmetric gait characteristics are of critical importance as excessive asymmetry may increase the severity of disability experienced by people with non-traumatic LLA and contribute to secondary pain conditions (low back pain and osteoarthritis), poor gait efficiency, declines in physical performance, and compromised skin integrity of the residual limb. Compared to individuals with traumatic LLA, the poor gait performance of those with non-traumatic LLA is further compounded by older age, lower premorbid function, presence of comorbidities, frequent wound development, and delayed healing in the residual limb. While improving gait symmetry is a goal of conventional prosthetic rehabilitation, persistence of gait asymmetry for years after LLA highlights the ineffectiveness of current rehabilitation practices in achieving this goal. As a means of improving gait symmetry, this study aims to determine the efficacy of error-manipulation gait training using two approaches (error-augmentation and error-correction) compared to current standard-of-care in a three-arm randomized controlled trial. Error-manipulation gait training intervention will be delivered in eight training sessions (2x/week, 4 weeks) with 54 Veterans (18 per intervention group, 18 in control group) who have non-traumatic, unilateral, transtibial LLA. It is unclear which, if either, form of error-manipulation gait training is efficacious for improving persistent gait symmetry in Veterans with non-traumatic LLA. Error-augmentation gait training is a promising and novel intervention that involves exaggerating an existing movement error to force the neuromuscular system to correct the error. While this form of gait training improved gait symmetry in small studies of individuals with chronic stroke or traumatic amputation, it has yet to be evaluated in older Veterans with non-traumatic LLA. In contrast, error-correction training involves reducing movement errors by overcorrecting for asymmetry. Both error-augmentation and error-correction gait training are based upon motor learning principles of distributed practice, task specificity, and feedback. Each of these error-manipulation interventions have potential advantages over traditional gait training following LLA which involves repeated bouts of walking with minimal feedback on movement quality and is often unsupervised. Therefore, the primary aim of this study is to determine the efficacy of error-manipulation gait training to improve gait symmetry. A secondary aim is to evaluate signals of efficacy for improved secondary measures of physical function. Lastly, this study will explore changes to residual limb skin health and prosthesis socket fit following error-manipulation gait training. The unique use of motor learning principles in error-manipulation gait training to improve gait symmetry addresses the problem of chronic gait asymmetry following non-traumatic LLA. The results of this study will advance rehabilitation knowledge and provide necessary evidence for the clinical translation of gait training protocols based in motor learning principles for the at-risk population of Veterans with non-traumatic LLA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial; Three groups
| Arm | Type | Receives |
|---|---|---|
| Error-augmentation training | Experimental | Behavioral: Error-augmentation gait trainingA 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). |
| Error-correction training | Experimental | Behavioral: Error-correction gait trainingA 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. |
| Supervised waking | Active comparator | Behavioral: Supervised walkingA 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 may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral, non-traumatic, transtibial amputation
- Diabetes mellitus and/or peripheral artery disease
- Able to ambulate in the community without assistive device
- Step length asymmetry during walking (>1.0 asymmetry index.)
- 6 months since amputation
Key exclusion criteria (5 listed)
- Unstable heart condition
- Including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis
- Acute systemic infection
- Active cancer treatment
- Traumatic or cancer related amputation etiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Error-augmentation gait trainingSplit-belt treadmill training to enhance between-limb asymmetry during treadmill walking, which is intended to force compensation and correction of step asymmetry during treadmill walking. The error-augmentation gait training program is delivered in 8 sessions over 4 weeks. | Behavioural | Error-augmentation training |
| Error-correction gait trainingMetronome will be set to cue participants to overcorrect between-limb step asymmetry during treadmill walking, through use of asymmetrical metronome tones in a 2:1 ratio. The error-correction gait training program is delivered in 8 sessions over 4 weeks. | Behavioural | Error-correction training |
| Supervised walkingAn active comparator intervention, in which a supervised treadmill walking program is delivered without attempt to correct step asymmetry. The supervised walking program is delivered in 8 sessions over 4 weeks. | Behavioural | Supervised waking |
Primary outcome
Step Length Symmetry
Time frame: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.
Measurement of step length symmetry by overground walking on GAITRite mat and kinetic and kinematic measurements using 3-D motion capture system.
3 secondary outcomes
Six-minute walk test
Time frame: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.
Free-living daily step count
Time frame: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.
World Health Organization Disability Assessment Scale 2.0
Time frame: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 37276273B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
- Derived from this study: PubMed 34379777Kline PW, So N, Fields T, Juarez-Colunga E, Christiansen CL. Error-Manipulation Gait Training for Veterans With Nontraumatic Lower Limb Amputation: A Randomized Controlled Trial Protocol. Phys Ther. 2021 Nov 1;101(11):pzab192. doi: 10.1093/ptj/pzab192.
- Individual participant dataSharing planned: No. Participant data will be made available at time of study completion, per VA recommendations and approval.
Related trials for Transtibial Amputation
Active, not recruiting
Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees
Amputation
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Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
RecruitingPhase 1
Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
Amputation, Transtibial Amputation - Unilateral
Recruiting
Transtibial Osseointegration
Amputation; Traumatic, Leg, Lower
Active, not recruitingEarly Phase 1
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
Transtibial Amputee, Transtibial Amputation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cory L. Christiansen, PhD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Error-augmentation gait training, Error-correction gait training and Supervised walking in people with Transtibial Amputation and Peripheral Artery Disease, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cory L Christiansen, PhD ((303) 724-9101, Cory.Christiansen@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Length Symmetry (time frame: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03995238, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.