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The Role of Visual Attention and Environmental Complexity in Real-world Mobility for People With Lower Limb Amputation

Recruitingn/aAges 18 Years - anyAllVirginia Commonwealth University
NCT07831707 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 p

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * fitted with terminal prosthesis * 20/60 vision or better (with or without glasses/contacts) Exclusion Criteria: * 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) * acute systemic infection * prisoner * inability to follow a 3-step command * concussion/brain injury in the past 12 months * active cancer treatment * preexisting neurological condition (i.e., multiple sclerosis, Parkinson's disease) * participating in prosthetic rehabilitation * color-blindness * history of seizure(s) * inability to read and communicate in English. Participants in the control group must meet the non-amputation-related criteria noted above, be within ±2 years and the same biological sex as their paired participants with LLA.
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What it tests

  • Comprehensive assessment of walking patterns and functional mobility
  • Comprehensive assessment of eye movements during walking
  • Questionnaire Assessments completed
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Where

1 site
Virginia Commonwealth University
Richmond, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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