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

RecruitingNAAges 18 Years - 85 YearsAllVirginia Commonwealth University
NCT07387744 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 clini

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Undergoing active cancer treatment * Participating in prosthetic rehabilitation * Clinical discretion of the principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the protocol * Inability to communicate verbally in English
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What it tests

  • Clinical Descriptive Measures related to amputation collected
  • GPS device education/distributed
  • activPAL device education/distributed
  • Questionnaire Assessments completed
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Where

1 site
Virginia Commonwealth University
Richmond, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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