What this study is
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.
What's being tested
- Error-augmentation gait training
Intervention · BEHAVIORAL
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 training
Intervention · BEHAVIORAL
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 walking
Intervention · BEHAVIORAL
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 details
- Official title
- Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation
- Sponsor
- VA Office of Research and Development
- Conditions
- Transtibial Amputation · Peripheral Artery Disease · Diabetes Mellitus
- Enrolling
- 54 people
- Starts
- 2019-10-09
- Est. completion
- 2026-10-31
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 89 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openRocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
- Ryan Stephenson, DO · Contact303-399-8020ryan.stephenson@va.gov
- Thomas Fields, DPT · Contact(720) 723-3372thomas.fields@va.gov
- Cory L. Christiansen, PhD · Principal investigator
RecruitingHunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States
- John Hermanson, MD · Contactjohn.hermanson@va.gov
- Benjamin Darter, DPT · Contactbenjamin.darter@va.gov
Recruiting
Study team
Sponsor
VA Office of Research and Development
Study ID A3237-R
Principal investigator
Cory L. Christiansen, PhD
Rocky Mountain Regional VA Medical Center, Aurora, CO
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.