Personalized Mobility Interventions for Amputation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assist people with leg amputations who use prosthetics but face mobility challenges. Researchers will analyze data from wearable sensors and smartphones to identify factors limiting prosthetic use, such as the prosthetic itself, physical issues, or psychological factors. Participants not meeting their mobility goals will receive personalized, needs-based interventions, like physical therapy or motivational support, to enhance their daily activities. Individuals with a lower limb amputation who can wear a prosthesis and have been struggling with its use might be well-suited for this trial. As an unphased study, this trial offers a unique opportunity to contribute to research that could improve prosthetic mobility solutions for many.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these personalized mobility interventions are safe?
Research shows that people using artificial limbs for their legs have different needs. A detailed review of studies has identified these main needs. Understanding them helps researchers create better support methods for using prostheses. The personalized methods tested in this trial aim to meet these specific needs. Importantly, similar methods used in the past have not shown any major safety issues. These methods may include care for the prosthesis, physical therapy, or psychological support, which are generally safe and commonly used in regular care. Therefore, these treatments are considered safe for participants and focus on improving daily activities without significant risk.12345
Why are researchers excited about this trial?
Researchers are excited about these personalized mobility interventions for amputation because they tailor treatment based on the individual's unique needs. Unlike standard approaches that might offer a one-size-fits-all solution like basic physical therapy or prosthetic adjustments, this intervention uses detailed sensor monitoring and expert panel assessments to customize the care plan. The treatment might include a mix of prosthetic care, physical therapy, and even psychological support like motivational interviewing. This bespoke approach aims to significantly improve prosthesis use and enhance overall mobility, offering hope for better long-term outcomes.
What evidence suggests that these personalized mobility interventions could be effective for improving prosthesis use?
Research has shown that personalized mobility programs can help people with amputations. In a previous study, 68% of participants who received these customized programs improved their ability to move or reached their mobility goals. Among those who improved, 46% exceeded expectations. In this trial, participants not meeting mobility goals after initial monitoring will receive a needs-based intervention tailored to their individual requirements. This intervention may include prosthetic care, physical therapy, or motivational support. The goal is to help people use their prostheses more effectively and achieve their daily activity goals.678910
Who Is on the Research Team?
Arun Jayaraman, PT, PhD
Principal Investigator
Shirley Ryan AbilityLab
Are You a Good Fit for This Trial?
This trial is for individuals aged 18-89 with lower-limb amputations at the transtibial or transfemoral level, who can wear a prosthesis and are classified as K-level 2 - 4. It's open to Veterans Affairs participants receiving care through their system. People with conditions like stroke, severe obesity, or neuralgia that limit prosthesis use independently of training aren't eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Monitoring
Participants are monitored using sensors to assess prosthesis use and mobility goals
Intervention
Participants not meeting mobility goals receive targeted interventions such as prosthetic care, physical therapy, or motivational interviewing
Post-Intervention Monitoring
Participants are monitored to assess the maintenance of prosthesis use after intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Needs-based intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shirley Ryan AbilityLab
Lead Sponsor
Walter Reed National Military Medical Center
Collaborator
Minneapolis Veterans Affairs Medical Center
Collaborator