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

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Amputation

Treatments: Other: Questionnaire Assessments completed; Other: activPAL device education/distributed; Other: Clinical Descriptive Measures related to amputation collected; Other: GPS device education/distributed

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07387744

K12TR004364 (U.S. NIH Grant/Contract)

HM20033204

Details and patient eligibility

About

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.

Full description

Poor understanding of the multiple mobility modes used by people with lower limb amputation (LLA) is a likely contributor high rates of self-reported disability, poor social engagement, and lower quality of life. Understanding mobility patterns in this population is essential for developing targeted interventions, optimizing assistive technologies, and improving overall community mobility. This study addresses three limitations in rigor of prior research on community mobility in people with LLA: 1) minimal use of objectively-monitored community mobility, 2) unknown contexts of ambulatory and wheeled mobility behaviors, 3) unclear relationship between patient and clinical factors influencing mode of community mobility.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Lower Limb Amputation (LLA) Participants

Experimental group

Description:

People with lower limb amputation will be targeted as this is the population of interest for this study.

Treatment:

Other: GPS device education/distributed

Other: Clinical Descriptive Measures related to amputation collected

Other: Questionnaire Assessments completed

Other: activPAL device education/distributed