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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT07831707
Status
Recruiting

Conditions

  • Lower Limb Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Comprehensive assessment of walking patterns and functional mobility — OTHER
    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
    Comprehensive assessment of eye movements during walking including Target Fixation Time (seconds; %) and Number of fixations
  • Questionnaire Assessments completed — OTHER
    The following assessments will be completed: World health organization disability assessment schedule 2.0 (WHODAS), and Activities Specific Balance Confidence Scale.

Study Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Oct 25, 2025
Status verified
Sep 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Subjects with Lower Limb Amputation (LLA)
    20 participants with below knee amputation.
  • Arm: Matched Control
    10 sex- and age-matched control participants.

Primary Outcome Measure

Gait Analysis-Walking Speed [ Time Frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23239
Paul Kline
804-828-4483
Paul Kline (PRINCIPAL_INVESTIGATOR)

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