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

NCT03995238 | Recruiting

• 1 other identifier: A3237-R
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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

Diabetes Mellitus; Transtibial Amputation; Peripheral Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Step Length Symmetry

  Measurement of step length symmetry by overground walking on GAITRite mat and kinetic and kinematic measurements using 3-D motion capture system.

  Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.

Secondary Outcomes (3)

• Six-minute walk test

  Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.

• Free-living daily step count

  Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.

• World Health Organization Disability Assessment Scale 2.0

  Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.

Other Outcomes (2)

• Transcutaneous oximetry

  Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.

• Socket Comfort Score

  Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.

Study Arms (3)

Error-augmentation training

EXPERIMENTAL

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).

Behavioral: Error-augmentation gait training

Error-correction training

EXPERIMENTAL

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.

Behavioral: Error-correction gait training

Supervised waking

ACTIVE COMPARATOR

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.

Behavioral: Supervised walking

Interventions

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.

Error-correction training

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-augmentation training

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.

Supervised waking

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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.)
• months since amputation

You may not qualify 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

RECRUITING

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

RECRUITING

Related Publications (2)

• B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.

  PMID: 37276273 DERIVED

• Kline PW, So N, Fields T, Juarez-Colunga E, Christiansen CL. Error-Manipulation Gait Training for Veterans With Nontraumatic Lower Limb Amputation: A Randomized Controlled Trial Protocol. Phys Ther. 2021 Nov 1;101(11):pzab192. doi: 10.1093/ptj/pzab192.

  PMID: 34379777 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Cory L. Christiansen, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cory L Christiansen, PhD

CONTACT

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

Ryan Stephenson, DO

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group assignment and participants will be reminded at the time of testing to not disclose any aspects of the training sessions. The Principal Investigator will also remain blinded to group assignment. A co-investigator, who is not involved in participant testing/intervention, will manage randomization and maintenance of group assignment codes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial; Three groups

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: October 9, 2019
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)