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Prosthetic Device

New Prosthetic Foot for Amputation

N/A
Waitlist Available
Research Sponsored by Little Room Innovations, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18-89 years old
Unilateral transtibial amputation
Must not have
Unable to perform walking for 2 minutes without an assistive device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 day
Awards & highlights

Summary

"This trial aims to test a new type of prosthetic foot designed for individuals with lower leg amputations. The goal is to see if this new prosthetic can provide similar benefits to those with longer

Who is the study for?
This trial is for individuals with transtibial amputation who have long residual limbs and are in need of a prosthetic foot. It's designed to test if a new low-profile prosthetic can provide the same benefits as taller ones typically used by those with shorter residual limbs.
What is being tested?
The study is testing a novel layered low-profile prosthetic foot against prescribed ankles, aiming to offer enhanced compliance without losing strength. The goal is to see if it works well for people with longer below-knee amputations.
What are the potential side effects?
While specific side effects aren't listed, participants may experience discomfort or issues related to the fit and function of the new prosthesis compared to their current one.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 89 years old.
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I have had one leg amputated below the knee.
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I use a low profile foot orthotic daily.
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I understand the study details and agree to follow its rules.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot walk for 2 minutes without help like a walker.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ankle Range of Motion (ROM)
Total Energy Stored (TES)
Secondary study objectives
Ankle Quasi-Stiffness (AQS)
Device Satisfaction survey of the Orthotics and Prosthetics Users Survey (OPUS)
Rollover Shape from Motion Capture
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Prescribed Ankle vs. Layered Low Profile Foot (LPF)Experimental Treatment2 Interventions
In this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF.
Group II: Layered Low Profile Foot (LPF) vs. Prescribed AnkleExperimental Treatment2 Interventions
In this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Layered Low Profile Foot
2024
N/A
~10
Prescribed Ankle
2024
N/A
~10

Find a Location

Who is running the clinical trial?

Kennesaw State UniversityOTHER
11 Previous Clinical Trials
716 Total Patients Enrolled
Little Room Innovations, LLCLead Sponsor
~4 spots leftby Sep 2025
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