Recruiting

Mobility After LLA

Sponsor:

Virginia Commonwealth University

Code:

NCT07387744

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Clinical Descriptive Measures related to amputation collected

GPS device education/distributed

activPAL device education/distributed

Questionnaire Assessments completed

Study Details

Brief 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.

Conditions

Amputation

Study ID

NCT07387744

Start date

Apr 21, 2026

Status verified date

Jul, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Lower Limb Amputation (LLA) Participants

People with lower limb amputation will be targeted as this is the population of interest for this study.

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

Primary outcome measure

  • World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF) [ Time Frame: Visit 1 (Baseline) only/no repeated measures ]
  • Prosthesis Evaluation Questionnaire - Mobility subscale [ Time Frame: Visit 1 (Baseline) only/no repeated measures ]
  • Locomotor Capabilities Index [ Time Frame: Visit 1 (Baseline) only/no repeated measures ]
  • Modified telephone interview for cognitive status [ Time Frame: Visit 1 (Baseline) only/no repeated measures ]
  • Life Space Assessment [ Time Frame: Visit 1 (Baseline) only/no repeated measures ]
  • Houghton Scale [ Time Frame: Visit 1 (Baseline) only/no repeated measures ]
  • World health organization disability assessment schedule 2.0 (WHODAS) [ Time Frame: Visit 1 (Baseline) only/no repeated measures ]
  • Activities-specific balance confidence scale [ Time Frame: Visit 1 (Baseline) only/no repeated measures ]
  • GPS Outcomes (spatial and temporal metrics of community mobility):Total Distance Traveled (m) [ Time Frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2 ]
  • GPS Outcomes (spatial and temporal metrics of community mobility): Average movement speed (km/hr) [ Time Frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2 ]
  • GPS Outcomes (spatial and temporal metrics of community mobility): Size of movement area (km2) [ Time Frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2 ]
  • GPS Outcomes (spatial and temporal metrics of community mobility): Percentage of time spent outside the home [ Time Frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2 ]
  • GPS Outcomes (spatial and temporal metrics of community mobility): Mean and median distance from home [ Time Frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2 ]
  • GPS Outcomes (spatial and temporal metrics of community mobility): Number of locations visited [ Time Frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2 ]
  • GPS Outcomes (spatial and temporal metrics of community mobility): Max distance from home (km) [ Time Frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2 ]
  • GPS Outcomes (spatial and temporal metrics of community mobility): Frequency of out-of-home trips [ Time Frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2 ]
  • GPS Outcomes (spatial and temporal metrics of community mobility): Time and distance on foot [ Time Frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2 ]
  • activPAL Accelerometry: Daily duration (in minutes) of sitting, standing, and stepping [ Time Frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2 ]
  • activPAL Accelerometry: Daily step count [ Time Frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2 ]
  • activPAL Accelerometry: Daily walking bouts stepping cadence [ Time Frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2 ]

Central Contacts and Locations

Central contacts

Paul Kline

804-828-4483klinep@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Paul Kline

804-828-4483klinep@vcu.edu

Principal Investigator:

Paul Kline

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • Lower Limb Amputation (LLA)
  • Global Positioning System (GPS)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-07-27.