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.
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
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)
Single group
Clinical Descriptive Measures related to amputation collected
Other interventionOn 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.
GPS device education/distributed
Other interventionThe 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.
activPAL device education/distributed
Other interventionParticipants 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.
Questionnaire Assessments completed
Other interventionFor 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
World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF)
The (WHOQOL-BREF) is a standardized assessment of an individual's perceived quality of life across physical, psychological, social, and environmental domains. The WHOQOL-BREF is a widely used, 26-item self-report questionnaire from the World Health Organization that assesses an individual's Quality of Life (QOL) across four core domains: Physical Health, Psychological Health, Social Relationships, and Environment, plus two additional items for overall QOL and health. It's a brief, cross-culturally valid tool, derived from the longer WHOQOL-100, providing reliable data for research and clinical use by asking about experiences over the past two weeks on a 5-point scale. Higher scores (closer to 100) indicate better quality of life within that domain. Not evaluating any change, just a snapshot in time at Visit 1.
Prosthesis Evaluation Questionnaire - Mobility subscale
The Prosthesis Evaluation Questionnaire - Mobility subscale, captures a person's self reported ability to move and perform daily activities while using their prosthesis. It uses a 5-point ordinal scale (0-4). 0: Not able or hardly able to 4: No problem or almost fully able. The total scale ranges from 0 to 48. A higher score indicates more mobility. Not evaluating any change, just a snapshot in time at Visit 1.
Locomotor Capabilities Index
The Locomotor Capabilities Index measures a person's perceived ability to perform everyday mobility tasks using their prosthesis. The Locomotor Capabilities Index (LCI) is a validated, 14-item self-administered questionnaire used to assess the walking ability and independence of lower-limb amputees using a prosthesis. It evaluates a patient's perceived capability-what they believe they can do-rather than their actual everyday performance. The max score is 42. Not evaluating any change, just a snapshot in time at Visit 1.
Modified telephone interview for cognitive status
The Modified telephone interview for cognitive status is a brief, 13-item structured screening of global cognitive function suitable for remote administration. It is widely used in large-scale epidemiological studies and clinical practice to differentiate between normal aging, mild cognitive impairment (MCI), and dementia. Scores on the TICS-M range from 0 to 50, with higher scores indicating better cognitive health. Not evaluating any change, just a snapshot in time at Visit 1.
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Virginia Commonwealth University
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
