Improving walking for veterans with non-traumatic lower limb amputation
Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation
NA · VA Office of Research and Development · NCT03995238
This study is testing two different walking training programs to see if they can help veterans with non-traumatic lower limb amputations walk more evenly and improve their overall mobility.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 40 Years to 89 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT03995238 on ClinicalTrials.gov |
What this trial studies
This study focuses on enhancing gait symmetry in veterans who have undergone non-traumatic lower limb amputation due to conditions like diabetes and peripheral artery disease. It evaluates the effectiveness of two different gait training programs based on error manipulation techniques to address chronic gait asymmetry. The goal is to improve walking ability and reduce disability by optimizing rehabilitation methods for these veterans. Additionally, the study will assess the impact of these training programs on secondary measures of disability and the health of the residual limb.
Who should consider this trial
Good fit: Ideal candidates include veterans with unilateral, non-traumatic transtibial amputation who have diabetes mellitus and/or peripheral artery disease and can walk independently.
Not a fit: Patients with unstable heart conditions, active cancer treatment, or traumatic/cancer-related amputation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved walking ability and reduced long-term disability for veterans with non-traumatic lower limb amputation.
How similar studies have performed: Other studies have shown promise in using gait training techniques to improve walking outcomes, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Aurora, Colorado and 1 other locations
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States (RECRUITING)
- Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Cory L. Christiansen, PhD — Rocky Mountain Regional VA Medical Center, Aurora, CO
- Study coordinator: Cory L Christiansen, PhD
- Email: Cory.Christiansen@va.gov
- Phone: (303) 724-9101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Transtibial Amputation, Peripheral Artery Disease, Diabetes Mellitus, Amputation, Rehabilitation, Gait Training, Diabetes