Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation
Virginia Commonwealth University
50 participants
Apr 21, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria8
- 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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Interventions
On Visit 1 (baseline) Clinical measures will be collected including: Amputation level, date of amputation, amputation etiology, assistive device used and Medicare K level. The measures are intended for demographic and descriptive use.
The QStarz GPS data logger will be worn for all waking hours (from 8 am to 8 pm or beyond if awake), even on days they do not plan to leave home. The device is worn on a belt, in a pocket, or in a bag/pouch. Education on how to wear, maintain and charge the device will be provided.
Participants will wear a thigh-mounted activPAL micro accelerometer on their non-amputated limb (or longest residual limb if bilateral amputation). The activPAL sensor is small and lightweight, secured to the thigh with a waterproof dressing, and participants are instructed to wear it at all times (including sleep) unless swimming. Education on how to wear the device will be provided.
For visit #1 only, the following assessments will be completed: World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF), Prosthesis Evaluation Questionnaire - Mobility subscale, Locomotor Capabilities Index, Modified telephone interview for cognitive status, Life Space Assessment, Houghton Scale, World health organization disability assessment schedule 2.0 (WHODAS) and Activities-specific balance confidence scale
Locations(1)
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NCT07387744