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Recruiting NCT07387744

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

Trial Parameters

Condition Amputation
Sponsor Virginia Commonwealth University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2026-03
Completion 2027-08
Interventions
Clinical Descriptive Measures related to amputation collectedGPS device education/distributedactivPAL device education/distributed

Brief Summary

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

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 comm

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