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Prosthetic System

iFIT Prosthesis for Pediatric Limb Loss

N/A

Recruiting

Led By Timothy R Dillingham, MS,MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Intact, protective sensation in their residual limbs

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

Study Summary

This trialinvestigates an adjustable prosthetic system for children ages 3-18. Phase I develops a prototype and Phase II evaluates comfort and usability at home. Outcome measures include questionnaires, pressure and gait analysis.

Who is the study for?

This trial is for children aged 3-18 who have lost a limb due to trauma, birth defects, poor blood flow/diabetes, or cancer. They must be at least four months post-amputation with no open skin wounds, able to follow instructions and without severe pain or neurological issues affecting their other leg.Check my eligibility

What is being tested?

The study is testing the iFIT prosthesis—an adjustable prosthetic designed for kids' growth. It includes lab tests to finalize the prototype and a two-month home trial assessing comfort and function through questionnaires, pressure measurements inside the socket, and walking analysis.See study design

What are the potential side effects?

Since this trial involves a non-invasive prosthetic device rather than medication, traditional side effects are not applicable. However, potential issues may include discomfort with the fit of the prosthesis or skin irritation where it attaches to the limb.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can feel sensations in my amputated limb area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CAPP-PSI

Gait Speed

Internal Socket Pressures

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase IIExperimental Treatment1 Intervention

Phase II involves a two month home trial to determine the comfort and utility of an adjustable prosthetic system for children. Children will be fit at several different locations by their prosthetist with the adjustable socket. They will complete several questionnaires on their current device, as well as have internal socket pressures and a gait analysis completed. They will return one month later to complete the same outcome measures on their conventional device. They will also be given activity monitors to track their activity through the duration of the project.

Group II: Phase IExperimental Treatment1 Intervention

Phase I involves developing a final design for an adjustable, immediate fit prosthesis. We will recruit 5-10 participants age 3-12 to complete in-lab testing and evaluation of several designs. This testing will lead to the final product design to be tested in Phase II.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER

708 Previous Clinical Trials

8,581,263 Total Patients Enrolled

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,048 Total Patients Enrolled

Timothy R Dillingham, MS,MDPrincipal InvestigatorUniversity of Pennsylvania

Media Library

iFIT Prosthesis (Prosthetic System) Clinical Trial Eligibility Overview. Trial Name: NCT05230004 — N/A

Acute Lymphoblastic Leukemia Research Study Groups: Phase II, Phase I

Acute Lymphoblastic Leukemia Clinical Trial 2023: iFIT Prosthesis Highlights & Side Effects. Trial Name: NCT05230004 — N/A

iFIT Prosthesis (Prosthetic System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05230004 — N/A

Frequently Asked Questions

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

To whom is enrollment in this research endeavor available?

"To be eligible for this trial, participants must have pediatric status and fall between the ages of 3 to 18. At present, 40 candidates are being accepted into the study."

Answered by AI

Is this study open to participants who are 55 years of age or older?

"According to the trial's admission qualifications, only children between 3 and 18 years of age are eligible. There happen to be 27 studies that cater exclusively to participants below eighteen while 6 focus on seniors above sixty-five."

Answered by AI

What is the maximum capacity for enrollees in this investigation?

"Indeed, according to clinicaltrials.gov, this ongoing study is currently searching for 40 participants from one medical centre. The trial was first made available on September 1st 2021 and the last update occurred October 3rd 2022."

Answered by AI

Is the enrollment process open for this experiment?

"According to the clinicaltrials.gov database, this medical investigation is actively soliciting participants. The initial posting of the study dates back to September 1st 2021 and was most recently modified on October 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth

Timothy Dillingham 2021. "Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05230004.