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

NCT03930199 | Active Not Recruiting

• 1 other identifier: STU00208186
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Prosthesis; Amputation; Prosthetic; Amputee; Smartphone; Sensors; Mobility

Outcome Measures

Primary Outcomes (9)

• Pre-intervention:10 Meter Walk Test (10MWT)

  Assesses subject walking speed in meters per second for 10 meters. Subjects will repeat each measure 3 times at their normal self-selected walking speed and 3 times at a fast speed while still able to maintain safety.

  Week 12-13

• Pre-intervention: 6 Minute Walk Test (6MWT)

  The 6 minute walk test is performed as an objective evaluation of functional exercise capacity. The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded.

  Week 12-13

• Pre-intervention: Berg Balance Scale Test

  This test is a standardized 14-item objective measure of postural stability and static balance; it is an established fall predictor in adults. Balance is measured during various tasks on a 5 point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function, with a total possible score of 56. A score of 20 or less indicates a high fall risk.

  Week 12-13

• Post-intervention:10 Meter Walk Test (10MWT)

  Assesses subject walking speed in meters per second for 10 meters. Subjects will repeat each measure 3 times at their normal self-selected walking speed and 3 times at a fast speed while still able to maintain safety.

  Week 24-25

• Post-intervention: 6 Minute Walk Test (6MWT)

  The 6 minute walk test is performed as an objective evaluation of functional exercise capacity. The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption.

  Week 24-25

• Post-intervention: Berg Balance Scale Test

  This test is a standardized 14-item objective measure of postural stability and static balance; it is an established fall predictor in adults. Balance is measured during various tasks on a 5 point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function, with a total possible score of 56. A score of 20 or less indicates a high fall risk.

  Week 24-25

• Delayed post-intervention:10 Meter Walk Test (10MWT)

  Assesses subject walking speed in meters per second for 10 meters. Subjects will repeat each measure 3 times at their normal self-selected walking speed and 3 times at a fast speed while still able to maintain safety.

  Week 40-41

• Delayed post-intervention: 6 Minute Walk Test (6MWT)

  The 6 minute walk test is performed as an objective evaluation of functional exercise capacity. The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption.

  Week 40-41

• Delayed post-intervention: Berg Balance Scale Test

  This test is a standardized 14-item objective measure of postural stability and static balance; it is an established fall predictor in adults. Balance is measured during various tasks on a 5 point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function, with a total possible score of 56. A score of 20 or less indicates a high fall risk.

  Week 40-41

Secondary Outcomes (6)

• Pre-intervention: Amputee Mobility Predictor (AMP)

  Week 12-13

• Pre-intervention: Modified Falls Efficacy Scale (mFES)

  Week 12-13

• Post-intervention: Amputee Mobility Predictor (AMP)

  Week 24-25

• Post-intervention: Modified Falls Efficacy Scale (mFES)

  Week 24-25

• Delayed post-intervention: Amputee Mobility Predictor (AMP)

  Week 40-41

Study Arms (1)

Not Meeting Mobility Goals

EXPERIMENTAL

After the first three months of sensor monitoring, participants not meeting goals will receive an intervention (others will be removed from the study). The intervention assigned is not pre-determined, but will be assigned by an expert panel based on the individual needs determined from the assessment results and monitoring data. The intervention may include prosthetic care, physical therapy, motivational interviewing or other related psychological interventions, or a combination thereof. After three months of intervention, assessments are performed again and if improvement in prosthesis use is determined, participants are monitored for another three months to assess maintenance of prosthesis use (participants showing no improvement are removed from the study before these final three months of monitoring).

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

Interventions

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

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.

Not Meeting Mobility Goals

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Walter Reed National Military Medical Center: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator

Study Sites (3)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Walter Reed National Military Medical Center, Center for Rehabilitation Sciences Research

Bethesda, Maryland, 20889, United States

Location

Minneapolis Veterans Affairs Health Care System

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (2)

• McGuire M, Nataletti S, Maronati R, Hoppe-Ludwig S, Banerjee A, Wacek A, Cave J, Looft JM, Dearth CL, Hendershot BD, Jayaraman A. References values and standardized testing protocols for performance-based and patient-reported outcome measures among individuals with lower limb amputation. Front Rehabil Sci. 2026 Mar 13;7:1786298. doi: 10.3389/fresc.2026.1786298. eCollection 2026.

  PMID: 41908176 DERIVED

• B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.

  PMID: 37276273 DERIVED

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Upon enrollment, participants will be provided two sensors to track mobility and prosthesis use. Participants will wear the sensors continuously for 3 months and then will return to complete a set of assessments. The result of these assessments and analysis of sensor data will determine if the participant is meeting mobility goals and expected prosthesis use. Participants not meeting goals or prosthesis use will receive an intervention for 3 months. The intervention may include prosthetic care and physical therapy, or motivational interviewing, or both. During these 3 months, sensors will continue to monitor activity. After completion of intervention, participants will repeat the set of assessments and those who have improved in mobility goals and/or prosthesis use will continue to be monitored with sensors for an additional 3 months, after which the set of assessments will be completed a final time, assessing the maintenance of mobility goals and prosthesis use.

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 29, 2019
• Study Start: May 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (3)