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 — OTHERAssessment 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 — OTHERComprehensive assessment of eye movements during walking including Target Fixation Time (seconds; %) and Number of fixations
- Questionnaire Assessments completed — OTHERThe 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 Control10 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
- Paul Kline804-828-4483
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23239 | Paul Kline (PRINCIPAL_INVESTIGATOR) |