What this study is
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.
What's being tested
- Comprehensive assessment of walking patterns and functional mobility
Intervention · 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
Intervention · OTHER
Comprehensive assessment of eye movements during walking including Target Fixation Time (seconds; %) and Number of fixations
- Questionnaire Assessments completed
Intervention · OTHER
The following assessments will be completed: World health organization disability assessment schedule 2.0 (WHODAS), and Activities Specific Balance Confidence Scale.
Study details
- Sponsor
- Virginia Commonwealth University
- Conditions
- Lower Limb Amputation
- Enrolling
- 30 people
- Starts
- 2025-10-25
- Est. completion
- 2027-05-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVirginia Commonwealth University
Richmond, Virginia, United States
- Paul Kline · Contact804-828-4483klinep@vcu.edu
- Paul Kline · Principal investigator
Recruiting
Study team
Sponsor
Virginia Commonwealth University
Study ID HM20030568
Principal investigator
Paul Kline
Virginia Commonwealth University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.