Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation

Overview

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.

Detailed description

Poor understanding of the multiple mobility modes used by people with lower limb amputation (LLA) is a likely contributor high rates of self-reported disability, poor social engagement, and lower quality of life. Understanding mobility patterns in this population is essential for developing targeted interventions, optimizing assistive technologies, and improving overall community mobility. This study addresses three limitations in rigor of prior research on community mobility in people with LLA: 1) minimal use of objectively-monitored community mobility, 2) unknown contexts of ambulatory and wheeled mobility behaviors, 3) unclear relationship between patient and clinical factors influencing mode of community mobility.

Interventions

• Other 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.
• Other 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.
• Other 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.
• Other 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 measures

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT07387744 · HM20033204 · K12TR004364

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗