Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID07387744

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

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessments and Device Education

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)

Community Mobility Monitoring

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

Data Collection and Device Return

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

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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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