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

Conditions

• Diabetes Mellitus
• Peripheral Artery Disease
• Transtibial Amputation

Eligibility Criteria

Sex

ALL

Age

40 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• Error-augmentation gait training — 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 — 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 — 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

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.

Key Dates

Start date

Oct 9, 2019

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

54 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Cory L Christiansen, PhD
  (303) 724-9101
  [email protected]
• Ryan Stephenson, DO
  (303) 399-8020
  [email protected]

Locations (2)

Find similar trials in Aurora, CO

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