Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation

ConditionAmputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorVirginia Commonwealth University

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

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Virginia Commonwealth University

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator