Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users

Running, not enrolling · Not applicable

Conditions studied: Amputation

In brief

The goal of this research is to analyze data from smartphone-based and wearable sensors, using advanced machine-learning and data-mining techniques, and to combine this information with performance-based measures, participant-reported measures, and structured interviews to create a clinical toolbox to (i) identify individuals who exhibit reduced prosthesis use (compared to expected usage levels based on K-level designation and/or participant goals of community mobility and social interaction), (ii) identify prosthetic/physical and psychological factors that limit prosthesis use, and (iii) determine the effect of targeted interventions to increase prosthesis use and facilitate achievement of participant goals. Objective sensor-based measurement of home and community activities will allow for the correlation of real-world function to in-clinic assessments and to monitor changes resulting from rehabilitation interventions in real time. Machine-learning and data mining techniques will be used to identify a subset of measures from this toolbox that sensitively and accurately reflect real-world function, enabling clinicians to predict and assess activity and provide effective interventions to optimize prosthesis use. The goal of this project, to improve overall performance with respect to activities of daily living and other real-world activities, thus addresses the Fiscal Year 2017 (FY17) Orthotics and Prosthetics Outcomes Research Program (OPORP) Focus Area of Orthotic or Prosthetic Device Function.

Key facts

Study ID

NCT03930199

Run by

Shirley Ryan AbilityLab

People needed

66

Starts

2020-05-01

Expected to finish

2026-12-31

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral or bilateral lower limb amputation at transtibial or transfemoral level
• Ability to wear and use a prosthesis
• Designated K-level 2 - 4, or equivalent
• Prescription of definitive prosthesis
• Veterans Affairs participants must receive care through the Veterans Affairs or related remote-site clinic
• Age: 18-89 years-to reflect the age range of eligible participants at Department of Defense and Veterans Affairs study sites, including young, combat-injured Service Members and healthy older Veterans, aged 70-80.

You may not qualify if…

• Co-morbidities that limit prosthesis use, independently of prosthetic function, training, or motivation, such as stroke, obesity, severe traumatic brain injury, and neuralgia, which require interventions outside the scope of this study. Suitability to participate in the study will be determined by the individual's physician.
• Unable or unwilling to learn to use the smartphone app or to allow transmission of study data
• Unable or unwilling to provide informed consent
• Residing in an area with poor cell phone coverage

Where it is running

• Shirley Ryan AbilityLab — Chicago, Illinois, United States
• Walter Reed National Military Medical Center, Center for Rehabilitation Sciences Research — Bethesda, Maryland, United States
• Minneapolis Veterans Affairs Health Care System — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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