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

NCT03930199 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Amputation

Interventions

OTHER

Needs-based intervention (physical, psychological, or both)

Individuals identified as having physical issues (poor prosthesis fit, function, comfort or physical conditioning) will receive prosthetic care and physical therapy. This includes adjusting socket fit, component fit and repair, and in some instances replacement. Rehabilitation strategies include gait and prosthesis use retraining, balance fall-prevention, and range-of-motion training, strengthening, pain management, and activities of daily living training, based on participant-reported mobility goals. Individuals whose prosthesis use is reduced due to psychological issues will be provided with motivational interviewing and other related psychological interventions. During these interventions participant will be asked to set personal goals using a semi-structured interview that explores facilitators and barriers to wearing their prosthesis. If both physical and psychological issues are present, participant may receive both types of interventions simultaneously.

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    collaborator FED
  • Minneapolis Veterans Affairs Medical Center

    collaborator FED
  • Shirley Ryan AbilityLab

    lead OTHER

Principal Investigators

  • Arun Jayaraman, PT, PhD · Shirley Ryan AbilityLab

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03930199 on ClinicalTrials.gov