Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes.
Luciane B Aledi, Carolina Dq Flumignan, Virginia Fm Trevisani...
https://pubmed.ncbi.nlm.nih.gov/37276273Actively Recruiting
Phase Not Applicable
Age: 40Years - 89Years
All Genders
ID03995238
Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation
Led by VA Office of Research and Development · Updated on 2026-04-13
54
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different error-manipulation gait training programs to improve walking symmetry in older Veterans who have non-traumatic lower limb amputations, mainly caused by diabetes or peripheral artery disease. The study aims to reduce disability, improve physical function, and enhance skin health of the residual limb by addressing chronic gait asymmetry, which current rehabilitation methods often fail to correct. This is a randomized controlled trial sponsored by the VA Office of Research and Development, focusing on motor learning principles to optimize prosthetic rehabilitation outcomes. The trial compares three groups over a 4-week period with eight treadmill-based training sessions. One group receives error-augmentation gait training using a split-belt treadmill to exaggerate step asymmetry, another group receives error-correction gait training with an auditory metronome cue to overcorrect asymmetry, and a control group participates in supervised treadmill walking without asymmetry correction. Each session is structured to deliver specific training aimed at adjusting gait patterns for Veterans with unilateral transtibial amputations. Participants will be assessed before, immediately after, and 12 weeks following the intervention. Measurements include step length symmetry, walking distance in six minutes, daily step counts, and disability levels using the World Health Organization Disability Assessment Scale. Skin health of the residual limb and prosthesis socket fit will also be evaluated. The study involves close monitoring and aims to provide evidence for new rehabilitation approaches to improve long-term outcomes for Veterans with non-traumatic lower limb amputation.
CONDITIONS
Brief Title
Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation
Who Can Participate
Age: 40Years - 89Years
All Genders
Eligibility Criteria
You may qualify if you...
- Unilateral, non-traumatic, transtibial amputation
- Diagnosis of diabetes mellitus and/or peripheral artery disease
- Ability to walk in the community without using an assistive device
- Presence of step length asymmetry greater than 1.0 asymmetry index during walking
- At least 6 months have passed since amputation
You will not qualify if you...
- Unstable heart condition such as unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, or acute pericarditis
- Acute systemic infection
- Ongoing active cancer treatment
- Amputation caused by trauma or cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 4 weeks
Participants receive a 4-week, 8 session treadmill-based gait training program aiming to improve walking symmetry. This includes either error-augmentation gait training, error-correction gait training, or supervised walking without asymmetry correction.
8 training sessions (2 sessions per week)
Follow-up
Duration - 12 weeks
Participants are monitored for changes in gait symmetry, physical function, and residual limb health up to 12 weeks after the intervention ends.
Follow-up visits as scheduled
Trial Site Locations
Total: 2 locations
1
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045-7211
Actively Recruiting
2
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249
Actively Recruiting
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Research Team
C
Cory L Christiansen, PhD
R
Ryan Stephenson, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Error-Manipulation Gait Training for Veterans With Nontraumatic Lower Limb Amputation: A Randomized Controlled Trial Protocol.
Paul W Kline, Noel So, Thomas Fields...
https://pubmed.ncbi.nlm.nih.gov/34379777