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Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation
Sponsor: Virginia Commonwealth University
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.
Official title: Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-03
Completion Date
2027-08
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
Clinical Descriptive Measures related to amputation collected
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.
GPS device education/distributed
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.
activPAL device education/distributed
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.
Questionnaire Assessments completed
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)
Virginia Commonwealth University
Richmond, Virginia, United States