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

• ClinicalTrials.gov Identifier: NCT03995238
• Recruitment Status: Recruiting
• First Posted: June 21, 2019
• Last Update Posted: May 12, 2022
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Transtibial Amputation; Peripheral Artery Disease; Diabetes Mellitus	Behavioral: Error-augmentation gait training; Behavioral: Error-correction gait training; Behavioral: Supervised walking	Not Applicable

Detailed Description:

The focus of this study is to improve walking symmetry in order to optimize walking ability and reduce disability for Veterans with non-traumatic lower limb amputation (LLA). Over 80% of current LLAs are non-traumatic, resulting from complications of pathologies, such as diabetes mellitus and peripheral artery disease. Despite current declines in total amputation rate among Veterans, the population with non-traumatic LLA is growing. For example, from 2000 to 2004 the relative amputation rate decreased by 34%. However, due to an increase in the number of Veterans with diabetes during the same period, the population of Veterans with diabetes and initial LLA increased by 23%. Following LLA, excessive gait asymmetry is common. Asymmetric gait characteristics are of critical importance as excessive asymmetry may increase the severity of disability experienced by people with non-traumatic LLA and contribute to secondary pain conditions (low back pain and osteoarthritis), poor gait efficiency, declines in physical performance, and compromised skin integrity of the residual limb. Compared to individuals with traumatic LLA, the poor gait performance of those with non-traumatic LLA is further compounded by older age, lower premorbid function, presence of comorbidities, frequent wound development, and delayed healing in the residual limb. While improving gait symmetry is a goal of conventional prosthetic rehabilitation, persistence of gait asymmetry for years after LLA highlights the ineffectiveness of current rehabilitation practices in achieving this goal. As a means of improving gait symmetry, this study aims to determine the efficacy of error-manipulation gait training using two approaches (error-augmentation and error-correction) compared to current standard-of-care in a three-arm randomized controlled trial. Error-manipulation gait training intervention will be delivered in eight training sessions (2x/week, 4 weeks) with 54 Veterans (18 per intervention group, 18 in control group) who have non-traumatic, unilateral, transtibial LLA. It is unclear which, if either, form of error-manipulation gait training is efficacious for improving persistent gait symmetry in Veterans with non-traumatic LLA. Error-augmentation gait training is a promising and novel intervention that involves exaggerating an existing movement error to force the neuromuscular system to correct the error. While this form of gait training improved gait symmetry in small studies of individuals with chronic stroke or traumatic amputation, it has yet to be evaluated in older Veterans with non-traumatic LLA. In contrast, error-correction training involves reducing movement errors by overcorrecting for asymmetry. Both error-augmentation and error-correction gait training are based upon motor learning principles of distributed practice, task specificity, and feedback. Each of these error-manipulation interventions have potential advantages over traditional gait training following LLA which involves repeated bouts of walking with minimal feedback on movement quality and is often unsupervised. Therefore, the primary aim of this study is to determine the efficacy of error-manipulation gait training to improve gait symmetry. A secondary aim is to evaluate signals of efficacy for improved secondary measures of physical function. Lastly, this study will explore changes to residual limb skin health and prosthesis socket fit following error-manipulation gait training. The unique use of motor learning principles in error-manipulation gait training to improve gait symmetry addresses the problem of chronic gait asymmetry following non-traumatic LLA. The results of this study will advance rehabilitation knowledge and provide necessary evidence for the clinical translation of gait training protocols based in motor learning principles for the at-risk population of Veterans with non-traumatic LLA.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial; Three groups
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation
• Actual Study Start Date: October 9, 2019
• Estimated Primary Completion Date: October 31, 2023
• Estimated Study Completion Date: October 31, 2023

Arms and Interventions

Arm	Intervention/treatment
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).	Behavioral: 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.
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.	Behavioral: 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.
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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Step Length Symmetry [ Time Frame: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end. ]
   Measurement of step length symmetry by overground walking on GAITRite mat and kinetic and kinematic measurements using 3-D motion capture system.

Secondary Outcome Measures :

1. Six-minute walk test [ Time Frame: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end. ]
   Physical function test measuring the total distance walked in a span of six minutes.
2. Free-living daily step count [ Time Frame: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end. ]
   Accelerometer-based measurement of free-living daily step count
3. World Health Organization Disability Assessment Scale 2.0 [ Time Frame: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end. ]
   Self-reported assessment of disability using a scale from 0 to 100, with 0 representing no disability, and 100 representing full disability.

Other Outcome Measures:

1. Transcutaneous oximetry [ Time Frame: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end. ]
   Measurement of residual limb integumentary health.
2. Socket Comfort Score [ Time Frame: Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end. ]
   Measurement of limb-socket interface by rating of prosthetic socket fit using a scale from 0 to 10, with 0 representing the most uncomfortable socket fit and 10 representing the most comfortable socket fit.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 to 10 years 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

Contacts and Locations

Contacts

Contact: Cory L Christiansen, PhD; (303) 724-9101; Cory.Christiansen@va.gov

Contact: Noel L So, MD; (303) 399-8020; noel.so@va.gov

Locations

United States, Colorado

Rocky Mountain Regional VA Medical Center, Aurora, CO; Recruiting

Aurora, Colorado, United States, 80045

Contact: Noel L So, MD 303-399-8020 noel.so@va.gov

Contact: Thomas Fields, DPT (720) 723-3372 thomas.fields@va.gov

Principal Investigator: Cory L. Christiansen, PhD

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Cory L. Christiansen, PhD; Rocky Mountain Regional VA Medical Center, Aurora, CO

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03995238
• Other Study ID Numbers: A3237-R
• First Posted: June 21, 2019
• Last Update Posted: May 12, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Participant data will be made available at time of study completion, per VA recommendations and approval.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

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

Additional relevant MeSH terms:

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases