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Sensing System

ENABLE Sensing Pad for Prosthetic Leg Fitting in Below Knee Amputees (ENABLE Trial)

N/A
Recruiting
Research Sponsored by North Carolina State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Can comfortably walk 3 mins without pausing to rest
At least 1 year of experience using his/her prosthetic leg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the outcome is to evaluate the real pressure on the residual limb in ten 60-second walking trials.
Awards & highlights

ENABLE Trial Summary

This trial is testing a new way to make sure prosthetic legs fit well for amputees, by developing a system that tracks pressure distribution on the residual limb.

Who is the study for?
This trial is for individuals with a below-knee amputation who have been using their current prosthetic socket for at least 6 months without major issues. They should be able to walk comfortably for 3 minutes and have over a year's experience with their prosthetic leg. People with cognitive or visual impairments, pregnant women, or those with neuropathy in the residual limb cannot participate.Check my eligibility
What is being tested?
The study is testing an innovative ENABLE system designed to assess how well a prosthetic socket fits by tracking pressure distribution on the residual limb visually. Participants will use small pads and an ENABLE sensing pad within their usual prosthesis setup.See study design
What are the potential side effects?
There may not be direct side effects from using the ENABLE system as it's non-invasive, but participants might experience discomfort or skin irritation where the pads contact the skin of their residual limbs.

ENABLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk for 3 minutes without needing to rest.
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I have used my prosthetic leg for at least a year.
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The bone in my amputated leg is more than half as long as the one in my other leg.
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I have had one leg amputated below the knee.

ENABLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the outcome is to evaluate the real pressure on the residual limb in ten 60-second walking trials.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the outcome is to evaluate the real pressure on the residual limb in ten 60-second walking trials. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Discomfort chart
Secondary outcome measures
Pressure distribution on the residual limb

ENABLE Trial Design

1Treatment groups
Experimental Treatment
Group I: Transtibial patientExperimental Treatment2 Interventions
All the recruited participants will be included in this arm and will go through the socket manufacturing, fitting, and testing procedure.

Find a Location

Who is running the clinical trial?

North Carolina State UniversityLead Sponsor
33 Previous Clinical Trials
15,557 Total Patients Enrolled

Media Library

ENABLE Sensing Pad (Sensing System) Clinical Trial Eligibility Overview. Trial Name: NCT05425810 — N/A
Below Knee Amputation Research Study Groups: Transtibial patient
Below Knee Amputation Clinical Trial 2023: ENABLE Sensing Pad Highlights & Side Effects. Trial Name: NCT05425810 — N/A
ENABLE Sensing Pad (Sensing System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05425810 — N/A

Frequently Asked Questions

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

Can participants younger than twenty years old partake in this experiment?

"To be considered eligible for this medical trial, participants must be 18 years of age or older, but no more than 99."

Answered by AI

Is it possible to partake in this research study?

"This research initiative is actively seeking 3 participants, aged 18 to 99, who have undergone amputation. To qualify for this trial, potential candidates must possess a residual limb with fibula length of at least half the size on their unaffected side; be unilateral transtibial amputees; have used the same prosthetic leg for 1 year or more; use the current socket without major modifications and skin issues for 6 months or longer; and demonstrate an ability to trek continuously for 3 minutes."

Answered by AI

Are there any vacant slots for individuals to join this experiment?

"The latest data posted on clinicaltrials.gov indicates that this medical trial is actively searching for participants. It was initially published in April 2021, with the most recent update taking place at the end of June 2022."

Answered by AI

What is the participant cap for this investigation?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively recruiting patients. The study was first advertised on April 20th 2021 and has been regularly updated until June 28th 2022. Only 3 participants need to be enlisted from a single location."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
NC State University
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Most responsive sites:
  1. NC State University: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment
Ming Liu 2021. "R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05425810.
~1 spots leftby May 2025
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