About this trial
Mobility is a fundamental aspect of daily life, enabling individuals to participate in social, occupational, and recreational activities. Community mobility, defined as movement in environments outside the home, is particularly important for quality-of-life. Following lower limb amputation (LLA), mobility limitations are common and persistent. With rehabilitation and prosthetic training, many regain the ability to ambulate but results vary as only 25 - 58% of patients regain ambulatory ability and less than half of those who become ambulatory achieve sufficient ability to walk in community settings. As a result, \~40% of people with LLA are ambulatory but also use wheeled mobility (e.g., wheelchair, scooter) for some or all of their community mobility tasks. To date, the complementary role of wheeled and ambulatory mobility in maximizing community mobility has been overlooked, with clinical research overwhelmingly focused on assessing and improving ambulatory ability despite its impracticality for many community settings.
Eligibility criteria
Qualifiers
Unilateral or bilateral major lower limb amputation (e.g., proximal to or through the ankle joint)
>6 months since LLA Fitted with a prosthetic limb
Fitted with a prosthetic limb
Use a wheelchair or scooter for mobility for part of a day at least once per week
Disqualifiers
Unstable heart condition (including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis)
Acute systemic infection Prisoner or institutionalized such that self-determined mobility is restricted
Prisoner or institutionalized such that self-determined mobility is restricted
Decisionally challenged individuals (Modified Telephone Interview for Cognitive Status score ≤24)
Trial design
Treatments tested in this trial
- Clinical Descriptive Measures related to amputation collected
- GPS device education/distributed
- activPAL device education/distributed
- Questionnaire Assessments completed
Treatment groups
Sponsors and collaborators
Virginia Commonwealth University
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator