Recruiting

Gait Rehabilitation

Sponsor:

VA Office of Research and Development

Code:

NCT03995238

Conditions

Transtibial Amputation

Peripheral Artery Disease

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Error-augmentation gait training

Error-correction gait training

Supervised walking

Study Details

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.

Conditions

Transtibial Amputation

Peripheral Artery Disease

Diabetes Mellitus

Study ID

NCT03995238

Start date

Oct 9, 2019

Status verified date

Apr, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Error-augmentation training

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).

experimental: Error-correction training

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.

active comparator: Supervised waking

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.

Interventions

Error-augmentation gait training

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

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

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.

Primary outcome measure

  • Step Length Symmetry [ Time Frame: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end. ]

Central Contacts and Locations

Central contacts

Cory L Christiansen, PhD

(303) 724-9101Cory.Christiansen@va.gov

Ryan Stephenson, DO

(303) 399-8020ryan.stephenson@va.gov

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045-7211

Contacts

Ryan Stephenson, DO

303-399-8020ryan.stephenson@va.gov

Thomas Fields, DPT

(720) 723-3372thomas.fields@va.gov

Principal Investigator:

Cory L. Christiansen, PhD

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Recruiting

Richmond, Virginia, United States, 23249

Contacts

John Hermanson, MD

john.hermanson@va.gov

Benjamin Darter, DPT

benjamin.darter@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Amputation
  • Rehabilitation
  • Gait Training
  • Diabetes
  • Peripheral Artery Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-13.