NCT07387744 Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation
| NCT ID | NCT07387744 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Commonwealth University |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-06-21 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-06-21 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 communicate verbally in English
Contact & Investigator
Paul Kline
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT07387744 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07387744 currently recruiting?
Yes, NCT07387744 is actively recruiting participants. Contact the research team at klinep@vcu.edu for enrollment information.
Where is the NCT07387744 trial being conducted?
This trial is being conducted at Richmond, United States.
Who is sponsoring the NCT07387744 clinical trial?
NCT07387744 is sponsored by Virginia Commonwealth University. The principal investigator is Paul Kline at Virginia Commonwealth University. The trial plans to enroll 50 participants.