Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-89
SponsorVA Office of Research and Development
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.)
Disqualifiers
Unstable heart condition
Including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis
Acute systemic infection
Active cancer treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Error-augmentation gait training
BehavioralSplit-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
BehavioralMetronome 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
BehavioralAn 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.
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Error-augmentation trainingExperimental treatment 1 intervention
Group B: Error-correction trainingExperimental treatment 1 intervention
Group C: Supervised wakingActive comparator 1 intervention
Trial outcomes
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.
Time frame
Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.Secondary outcomes
1
Six-minute walk test
Physical function test measuring the total distance walked in a span of six minutes.
Time frame
Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.2
Free-living daily step count
Accelerometer-based measurement of free-living daily step count
Time frame
Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.3
World Health Organization Disability Assessment Scale 2.0
Self-reported assessment of disability using a scale from 0 to 100, with 0 representing no disability, and 100 representing full disability.
Time frame
Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.Other outcomes
1
Transcutaneous oximetry
Measurement of residual limb integumentary health.
Time frame
Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.2
Socket Comfort Score
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.
Time frame
Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.Sponsors and contacts
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Source ClinicalTrials.gov