AmputationNCT03930199
Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users
A study testing Needs-based intervention (physical, psychological, or both) in people with Amputation, run by Shirley Ryan AbilityLab at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Amputation
- What is being tested?
- Needs-based intervention (physical, psychological, or both)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Walter Reed National Military Medical Center, Center for Rehabilitation Sciences Research
Bethesda, Maryland, 20889
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Minneapolis Veterans Affairs Health Care System
Minneapolis, Minnesota, 55417
About this study
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.
Read the detailed description
The overall goal of this research is to create a clinical toolkit to predict prosthesis use and function in the community. With this toolkit, clinicians will be able best determine an individual's K-Level designation, resulting in increased prosthesis use.
Aim 1: Determine whether a participant's prosthesis use matches the assigned K-level and/or self-reported goals and, if not, determine the reason(s) using an expert panel to evaluate data from performance-related measures, participant-reported measures, and smartphone and prosthesis sensors (clinical toolbox).
Aim 2: Quantify the effects of targeted physical intervention (prosthesis repair/refit, physical rehabilitation) or psychological intervention (motivational interviewing) or both on activity levels and patient goals.
Aim 3: Identify measure(s) that sensitively predict prosthesis use to create a clinically deployable toolkit to evaluate and optimize prosthesis use in the community.
- Conditions
- Amputation
- Being tested
- Needs-based intervention (physical, psychological, or both)
- Keywords
- Prosthesis, Amputation, Prosthetic, Amputee, Smartphone, Sensors, Mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Needs-based intervention (physical, psychological, or both) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 40-41
Secondary outcomes (6)
Pre-intervention: Amputee Mobility Predictor (AMP)
The AMP is a tool used to predict the ambulatory potential of lower limb amputees, and measure function post-rehabilitation. It was developed to provide a more objective approach to rating amputees under the various K Classifications. The test can be performed with or without the prosthesis. The test involves activities of transfers, balance and walking. Score is out of 39 with each item scored in the range of 0-2.
Measured: Week 12-13
Pre-intervention: Modified Falls Efficacy Scale (mFES)
The mFES is self-report questionnaire consisting of 14 items which is designed to measure fear of falling in the elderly. It assesses an individual's perception of balance during activities of daily living by asking "how confident are you that you can do the following activities without falling."
Measured: Week 12-13
Post-intervention: Amputee Mobility Predictor (AMP)
The AMP is a tool used to predict the ambulatory potential of lower limb amputees, and measure function post-rehabilitation. It was developed to provide a more objective approach to rating amputees under the various K Classifications. The test can be performed with or without the prosthesis. The test involves activities of transfers, balance and walking. Score is out of 39 with each item scored in the range of 0-2.
Measured: Week 24-25
Post-intervention: Modified Falls Efficacy Scale (mFES)
The mFES is self-report questionnaire consisting of 14 items which is designed to measure fear of falling in the elderly. It assesses an individual's perception of balance during activities of daily living by asking "how confident are you that you can do the following activities without falling."
Measured: Week 24-25
Delayed post-intervention: Amputee Mobility Predictor (AMP)
The AMP is a tool used to predict the ambulatory potential of lower limb amputees, and measure function post-rehabilitation. It was developed to provide a more objective approach to rating amputees under the various K Classifications. The test can be performed with or without the prosthesis. The test involves activities of transfers, balance and walking. Score is out of 39 with each item scored in the range of 0-2.
Measured: Week 40-41
Delayed post-intervention: Modified Falls Efficacy Scale (mFES)
The mFES is self-report questionnaire consisting of 14 items which is designed to measure fear of falling in the elderly. It assesses an individual's perception of balance during activities of daily living by asking "how confident are you that you can do the following activities without falling."
Measured: Week 40-41
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 May 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, Minneapolis Veterans Affairs Medical Center
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930199
- Sponsor's protocol ID
- STU00208186
- Status last verified
- Jan 2026
- First submitted
- 25 Apr 2019
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nataletti S, Okita S, Sindorf J, O'Brien MK, Maronati R, McGuire M, Hoppe-Ludwig S, Banerjee A, Wacek A, Cave J, Looft JM, Hendershot BD, Jayaraman A. Predicting prosthesis use and mobility needs in lower limb amputees: a machine learning approach using clinical and actigraphy data. J Neuroeng Rehabil. 2026 Apr 9;23(1):165. doi: 10.1186/s12984-026-01954-3.
PubMed 41957611McGuire 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.
PubMed 41908176B 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.
PubMed 37276273
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users
- ClinicalTrials.gov ID
- NCT03930199
- Acronym / sponsor ID
- STU00208186
- Conditions
- Amputation
- Keywords
- Prosthesis, Amputation, Prosthetic, Amputee, Smartphone, Sensors, Mobility
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, Minneapolis Veterans Affairs Medical Center
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall goal of this research is to create a clinical toolkit to predict prosthesis use and function in the community. With this toolkit, clinicians will be able best determine an individual's K-Level designation, resulting in increased prosthesis use.
Aim 1: Determine whether a participant's prosthesis use matches the assigned K-level and/or self-reported goals and, if not, determine the reason(s) using an expert panel to evaluate data from performance-related measures, participant-reported measures, and smartphone and prosthesis sensors (clinical toolbox).
Aim 2: Quantify the effects of targeted physical intervention (prosthesis repair/refit, physical rehabilitation) or psychological intervention (motivational interviewing) or both on activity levels and patient goals.
Aim 3: Identify measure(s) that sensitively predict prosthesis use to create a clinically deployable toolkit to evaluate and optimize prosthesis use in the community.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Not Meeting Mobility Goals | Experimental | Other: Needs-based intervention (physical, psychological, or both)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). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Not Meeting Mobility Goals |
Primary outcome
Pre-intervention:10 Meter Walk Test (10MWT)
Time frame: Week 12-13
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.
Pre-intervention: 6 Minute Walk Test (6MWT)
Time frame: Week 12-13
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.
Pre-intervention: Berg Balance Scale Test
Time frame: Week 12-13
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.
Post-intervention:10 Meter Walk Test (10MWT)
Time frame: Week 24-25
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.
Post-intervention: 6 Minute Walk Test (6MWT)
Time frame: Week 24-25
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.
Post-intervention: Berg Balance Scale Test
Time frame: Week 24-25
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.
Delayed post-intervention:10 Meter Walk Test (10MWT)
Time frame: Week 40-41
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.
Delayed post-intervention: 6 Minute Walk Test (6MWT)
Time frame: Week 40-41
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.
Delayed post-intervention: Berg Balance Scale Test
Time frame: Week 40-41
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.
6 secondary outcomes
Pre-intervention: Amputee Mobility Predictor (AMP)
Time frame: Week 12-13
Pre-intervention: Modified Falls Efficacy Scale (mFES)
Time frame: Week 12-13
Post-intervention: Amputee Mobility Predictor (AMP)
Time frame: Week 24-25
Post-intervention: Modified Falls Efficacy Scale (mFES)
Time frame: Week 24-25
Delayed post-intervention: Amputee Mobility Predictor (AMP)
Time frame: Week 40-41
Delayed post-intervention: Modified Falls Efficacy Scale (mFES)
Time frame: Week 40-41
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 41957611Nataletti S, Okita S, Sindorf J, O'Brien MK, Maronati R, McGuire M, Hoppe-Ludwig S, Banerjee A, Wacek A, Cave J, Looft JM, Hendershot BD, Jayaraman A. Predicting prosthesis use and mobility needs in lower limb amputees: a machine learning approach using clinical and actigraphy data. J Neuroeng Rehabil. 2026 Apr 9;23(1):165. doi: 10.1186/s12984-026-01954-3.
- Derived from this study: PubMed 41908176McGuire 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.
- Derived from this study: PubMed 37276273B 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan AbilityLab
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needs-based intervention (physical, psychological, or both) in people with Amputation, run by Shirley Ryan AbilityLab at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-intervention:10 Meter Walk Test (10MWT) (time frame: Week 12-13). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03930199, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.