Actively Recruiting
Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation
Led by Virginia Commonwealth University · Updated on 2026-05-29
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Mobility is essential for daily life, helping people engage in social, work, and recreational activities. This research focuses on community mobility, which means moving around environments outside the home, in people who have had lower limb amputations (LLA). Many people with LLA face ongoing mobility challenges, with only a portion regaining enough ability to walk in community settings. The study aims to understand the combined use of walking and wheeled devices like wheelchairs or scooters, as previous research has mostly focused only on walking ability despite wheeled mobility being important for many. The study involves people with lower limb amputations who use prosthetic limbs and wheelchairs or scooters for mobility at least once a week. Participants will be provided education and devices to monitor their mobility, including a GPS data logger worn during waking hours and a thigh-mounted accelerometer worn continuously except during swimming. Various clinical measures related to amputation will be collected at the first visit, along with several questionnaires assessing quality of life, prosthesis use, cognitive status, and balance confidence. Participants will be involved in two visits where baseline assessments and device education occur, followed by 10 to 21 days of wearing monitoring devices to collect detailed data on their movement patterns. Researchers will analyze this information alongside clinical and questionnaire data to understand mobility behaviors better. The primary outcomes include quality of life, mobility scores, and spatial and temporal data from GPS and accelerometer devices. This information will help improve interventions and assistive technologies to enhance community mobility for people with lower limb amputations.
CONDITIONS
Brief Title
Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 85 years
- Unilateral or bilateral major lower limb amputation (at or above the ankle joint)
- More than 6 months since lower limb amputation
- Fitted with a prosthetic limb
- Use a wheelchair or scooter for mobility at least once per week
You will not qualify if you...
- Unstable heart conditions such as unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, or acute pericarditis
- Acute systemic infection
- Prisoners or institutionalized individuals with restricted self-determined mobility
- Cognitive impairment with Modified Telephone Interview for Cognitive Status score 24 or less
- Undergoing active cancer treatment
- Currently participating in prosthetic rehabilitation
- Patients deemed unsafe or inappropriate by the principal investigator
- Inability to communicate verbally in English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete various questionnaires and clinical descriptive measures related to their amputation. They also receive education on how to wear and maintain GPS and activPAL devices.
1 baseline visit (in-person)
Duration - 10 to 21 days
Participants wear GPS and activPAL devices to monitor their community mobility and activity levels, including movements, distances traveled, and step counts during waking hours and sleep where applicable.
Continuous device wear during monitoring period
Duration - 1 day
Participants return for a follow-up visit to download data from the GPS and activPAL devices and complete any final assessments.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
P
Paul Kline
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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