- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03930199
Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Shirley Ryan AbilityLab
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Maryland
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Bethesda, Maryland, United States, 20889
- Walter Reed National Military Medical Center, Center for Rehabilitation Sciences Research
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Minneapolis Veterans Affairs Health Care System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Not Meeting Mobility Goals
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).
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 12-13
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Pre-intervention: 6 Minute Walk Test (6MWT)
Time Frame: Week 12-13
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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.
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Week 12-13
|
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.
|
Week 12-13
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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.
|
Week 24-25
|
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.
|
Week 24-25
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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.
|
Week 24-25
|
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.
|
Week 40-41
|
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.
|
Week 40-41
|
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.
|
Week 40-41
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-intervention: Amputee Mobility Predictor (AMP)
Time Frame: Week 12-13
|
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.
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Week 12-13
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Pre-intervention: Modified Falls Efficacy Scale (mFES)
Time Frame: Week 12-13
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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."
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Week 12-13
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Post-intervention: Amputee Mobility Predictor (AMP)
Time Frame: Week 24-25
|
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.
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Week 24-25
|
Post-intervention: Modified Falls Efficacy Scale (mFES)
Time Frame: Week 24-25
|
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."
|
Week 24-25
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Delayed post-intervention: Amputee Mobility Predictor (AMP)
Time Frame: Week 40-41
|
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.
|
Week 40-41
|
Delayed post-intervention: Modified Falls Efficacy Scale (mFES)
Time Frame: Week 40-41
|
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."
|
Week 40-41
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STU00208186
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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