Recruiting

Mobility Assessment

Sponsor:

Virginia Commonwealth University

Code:

NCT07831707

Conditions

Lower Limb Amputation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Comprehensive assessment of walking patterns and functional mobility

Comprehensive assessment of eye movements during walking

Questionnaire Assessments completed

Study Details

Brief summary:

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.

Conditions

Lower Limb Amputation

Study ID

NCT07831707

Start date

Oct 25, 2025

Status verified date

Sep, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Subjects with Lower Limb Amputation (LLA)

20 participants with below knee amputation.

Matched Control

10 sex- and age-matched control participants.

Interventions

Comprehensive assessment of walking patterns and functional mobility

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

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

Questionnaire Assessments completed

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

Primary outcome measure

  • Gait Analysis-Walking Speed [ Time Frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1) ]
  • Gait Analysis-Stride Length [ Time Frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1) ]
  • Gait Analysis-Stride length asymmetry [ Time Frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1) ]
  • Cognitive Task Performance Cognitive Task Performance [ Time Frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1) ]
  • Cognitive Task Performance [ Time Frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1) ]
  • Functional Mobility (Two-minute Walk Test) [ Time Frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1) ]
  • Functional Mobility (Timed Up and Go) [ Time Frame: Visit 1 ]
  • Eye Tracking (Target Fixation Time) [ Time Frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1) ]
  • Eye Tracking (Number of fixations) [ Time Frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1) ]
  • Patient Reported Outcomes (Houghton Scale) [ Time Frame: Visit 1 ]
  • Patient Reported Outcomes (PEQ - Mobility subscale) [ Time Frame: Visit 1 ]
  • Patient Reported Outcomes (WHODAS) [ Time Frame: Visit 1 ]
  • Patient Reported Outcomes (Activities Specific Balance Confidence Scale) [ Time Frame: Visit 1 ]
  • Accelerometry (Daily duration of sitting, standing, stepping) [ Time Frame: Between Visit 1 and 2 (which is 10-14 days after visit 1) ]
  • Accelerometry (Daily step count) [ Time Frame: Between Visit 1 and 2 (which is 10-14 days after visit 1) ]
  • Accelerometry (Daily walking bouts stepping cadence) [ Time Frame: Between Visit 1 and 2 (which is 10-14 days after visit 1) ]

Central Contacts and Locations

Central contacts

Paul Kline

804-828-4483klinep@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23239

Contacts

Paul Kline

804-828-4483klinep@vcu.edu

Principal Investigator:

Paul Kline

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.