About this trial
Despite high medical expenses (\>$500K/patient), mobility improvements achieved during rehabilitation for people with lower limb amputation (LLA) fail to translate into improved real-world outcomes. Even with advances in prosthesis technology enabling faster gait speed, greater walking endurance, and improved mobility confidence, people with LLA report persistent dissatisfaction with real-world mobility, limited ability to walk in the community, and difficulty achieving recommended physical activity levels.
Real-world walking requires thinking and moving simultaneously (e.g., cognitive-motor dual-tasking), visually attending to the environment, and navigating varying terrain. In contrast, clinical mobility assessments are usually performed without additional visual or cognitive demands, in controlled environments, and on level surfaces. Current clinical tools used to assess ambulation progression during rehabilitation do not adequately assess these changes in people who have experienced LLA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
unilateral transtibial LLA of either dysvascular (diabetes, peripheral vascular disease, and/or infection) or traumatic etiology
18 years old minimum
able to ambulate 2 minutes without rest
9 months since LLA
Disqualifiers
congenital or cancer-related LLA
ankle-level or above LLA on the contralateral limb
residual limb wound or contralateral foot ulcer
unstable heart condition (including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis)
Trial population
We will compare gait speed (Aim1) and gaze behavior with eye-tracking glasses (Aim 2) during vision-based (visual puzzles) and non-vision-based (serial subtraction) cognitive-motor dual-tasking while walking on low and high complexity terrain in people with LLA (n=20) and matched controls (n=10).
Trial design
Cohort
Prospective
Treatments tested in this trial
Comprehensive assessment of walking patterns and functional mobility
Other interventionAssessment of accelerometry: Daily duration (minutes) of sitting, standing, stepping, Daily step count, Daily walking bouts stepping cadence, Timed Up and Go and Two-minute Walk Test
Comprehensive assessment of eye movements during walking
Other interventionComprehensive assessment of eye movements during walking including Target Fixation Time (seconds; %) and Number of fixations
Questionnaire Assessments completed
Other interventionThe following assessments will be completed: World health organization disability assessment schedule 2.0 (WHODAS), and Activities Specific Balance Confidence Scale.
Treatment groups
Trial outcomes
Primary outcomes
Gait Analysis-Walking Speed
Measure walking speed meters/second. Captured during dual-task and single-task walking, it is used to measure motor performance. Normal Speed: Healthy adults usually walk at 1.2 to 1.4 meters per second.Fall Risk: A speed below 1.0 meter per second shows a higher risk for falls.Frailty Warning: A speed below 0.6 to 0.8 meters per second suggests a high risk of functional decline or disability.
Gait Analysis-Stride Length
Measure the stride length in meters. stride length is the total distance covered during one full cycle of walking or running with the same foot. It measures the space from where one foot touches the ground to when that exact same foot touches the ground again.
Gait Analysis-Stride length asymmetry
Assess Stride length asymmetry is an imbalance where the distance covered by the right and left steps differs. Symmetry Index (SI): Compares spatial step metrics or temporal single-limb support times between limbs.Percentage difference: Calculated by contrasting mean left and right step values; values exceeding 10% typically indicate notable dysfunction.
Cognitive Task Performance Cognitive Task Performance
Accuracy (percentage correct) of each cognitive task. This reflects cognitive performance and is measured in both dual-task and single-task conditions.
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