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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVirginia Commonwealth University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Comprehensive assessment of walking patterns and functional mobility

    Other intervention

    Assessment 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 intervention

    Comprehensive assessment of eye movements during walking including Target Fixation Time (seconds; %) and Number of fixations

  • Questionnaire Assessments completed

    Other intervention

    The following assessments will be completed: World health organization disability assessment schedule 2.0 (WHODAS), and Activities Specific Balance Confidence Scale.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Subjects with Lower Limb Amputation (LLA)3 interventions
Group B: Matched Control3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
2

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.

Time frame
Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
3

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.

Time frame
Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
4

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.

Time frame
Visit 1 and visit 2 (which will take place 10-14 days after visit 1)

Secondary outcomes

Other outcomes

Sponsors and contacts

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