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Personalized Mobility Interventions for Amputation

N/A
Waitlist Available
Led By Arun Jayaraman, PT, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unilateral or bilateral lower limb amputation at transtibial or transfemoral level
Ability to wear and use a prosthesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 40-41
Awards & highlights

Study Summary

This trial aims to use smartphones and wearable sensors, combined with performance and self-reported measures, to create a toolbox to identify factors that limit prosthesis use. The eventual goal is to use this information to provide more effective interventions to improve overall performance in activities of daily living.

Who is the study for?
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.Check my eligibility
What is being tested?
The study aims to improve how lower-limb prostheses are used by analyzing sensor data from smartphones and wearables using machine learning. The goal is to create tools for clinicians to identify usage issues and provide interventions based on real-world activity monitoring.See study design
What are the potential side effects?
Since this trial focuses on mobility interventions rather than medication, traditional side effects aren't applicable. However, participants may experience discomfort or challenges while adapting to new intervention strategies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had one or both of my legs amputated above or below the knee.
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I can wear and use a prosthesis.
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My mobility level is moderately to fully active.
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I have been prescribed a permanent prosthesis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 40-41
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 40-41 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Delayed post-intervention: 6 Minute Walk Test (6MWT)
Delayed post-intervention: Berg Balance Scale Test
Delayed post-intervention:10 Meter Walk Test (10MWT)
+6 more
Secondary outcome measures
Delayed post-intervention: Amputee Mobility Predictor (AMP)
Delayed post-intervention: Modified Falls Efficacy Scale (mFES)
Post-intervention: Amputee Mobility Predictor (AMP)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Not Meeting Mobility GoalsExperimental Treatment1 Intervention
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).

Find a Location

Who is running the clinical trial?

Walter Reed National Military Medical CenterFED
137 Previous Clinical Trials
34,431 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
72 Previous Clinical Trials
14,854 Total Patients Enrolled
Shirley Ryan AbilityLabLead Sponsor
193 Previous Clinical Trials
16,819 Total Patients Enrolled

Media Library

Needs-based intervention Clinical Trial Eligibility Overview. Trial Name: NCT03930199 — N/A
Amputation Research Study Groups: Not Meeting Mobility Goals
Amputation Clinical Trial 2023: Needs-based intervention Highlights & Side Effects. Trial Name: NCT03930199 — N/A
Needs-based intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03930199 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for the clinical trial?

"The clinical trial, posted on May 1st 2020, is currently recruiting according to the data hosted by clinicaltrials.gov and has been recently edited as of October 24th 2022."

Answered by AI

What qualifications must participants meet in order to take part in this trial?

"This clinical trial seeks 125 individuals with amputations, between the ages of 18-89. The criteria for applicants includes: being a Veteran Affairs participant who can access remote site care, able to wear and use prosthetic limbs, have experienced unilateral or bilateral lower limb amputation at transtibial or transfemoral level."

Answered by AI

What key goals are being sought through this research effort?

"This trial seeks to assess the efficacy of their intervention at Weeks 24-25 via a 10 Meter Walk Test (10MWT). Secondary objectives include evaluating balance and mobility with pre-intervention Modified Falls Efficacy Scale (mFES) questions, post-intervention Amputee Mobility Predictor (AMP), and further mFES inquiries."

Answered by AI

Are individuals aged 45 or above being incorporated into this experiment?

"This trial is recruiting individuals whose age lies between 18 and 89 years."

Answered by AI

How many individuals have consented to participate in this investigation?

"To successfully complete this medical trial, 125 suitable individuals must enroll. Those interested can join at Minneapolis Veterans Affairs Health Care System in Minneapolis, Minnesota or Walter Reed National Military Medical Center, Centre for Rehabilitation Sciences Research in Bethesda, Maryland."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users
Arun Jayaraman, PT, PhD 2020. "Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03930199.
~0 spots leftby Apr 2024
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