RecruitingNot ApplicableNCT03995238

Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation

Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation


Sponsor

VA Office of Research and Development

Enrollment

54 participants

Start Date

Oct 9, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 89 Years

Inclusion Criteria5

  • 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.)
  • months since amputation

Exclusion Criteria5

  • 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

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Interventions

BEHAVIORALError-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.

BEHAVIORALError-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.

BEHAVIORALSupervised 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.


Locations(2)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States

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NCT03995238


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