NCT03995238 Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation
| NCT ID | NCT03995238 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Transtibial Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2019-10-09 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2019-10-09 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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
Contact & Investigator
Cory L. Christiansen, PhD
PRINCIPAL INVESTIGATOR
Rocky Mountain Regional VA Medical Center, Aurora, CO
Frequently Asked Questions
Who can join the NCT03995238 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 89 Years, studying Transtibial Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03995238 currently recruiting?
Yes, NCT03995238 is actively recruiting participants. Contact the research team at Cory.Christiansen@va.gov for enrollment information.
Where is the NCT03995238 trial being conducted?
This trial is being conducted at Aurora, United States, Richmond, United States.
Who is sponsoring the NCT03995238 clinical trial?
NCT03995238 is sponsored by VA Office of Research and Development. The principal investigator is Cory L. Christiansen, PhD at Rocky Mountain Regional VA Medical Center, Aurora, CO. The trial plans to enroll 54 participants.