Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Amputation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 89 years
- Gender
- Both males and females
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 pr...
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.
Tracking Information
- NCT #
- NCT03930199
- Collaborators
- Walter Reed National Military Medical Center
- Minneapolis Veterans Affairs Medical Center
- Investigators
- Principal Investigator: Arun Jayaraman, PT, PhD Shirley Ryan AbilityLab
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