Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth

NCT05230004 | Active Not Recruiting

• 1 other identifier: 849980
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

An immediate fit adjustable prosthetic system is being investigated for children. The age range being recruited is from 3 years up to 18 years old. Phase I of this study will involve developing a final prototype by conducting in-lab testing on children with limb loss. Phase II will involve a two month home trial to further evaluate the comfort and usability of the socket. Outcome measures include a PEQ-based questionnaire, socket pressure measures and gait analysis.

Conditions

Limb Deficiencies; Pediatric ALL

Keywords

prosthesis; limb deficiency; limb loss; pediatric

Outcome Measures

Primary Outcomes (6)

• Modified Prosthetic Evaluation Questionnaire

  Evaluation questionnaire for prosthesis. Questions selected from PEQ are rated from 1-poor, to 5 excellent. 70 points total

  2 months

• Internal Socket Pressures

  Fujifilm pressure paper will be taped to the inside of the conventional socket and test socket to determine internal pressure values. Participants will walk at a self selected walking speed for 30 seconds.

  2 months

• Socket Comfort Score

  Rating of socket comfort from 0 very uncomfortable to 10 very comfortable

  2 months

• Gait Speed

  Participants will walk at a self-selected walking speed while being recorded by 3d motional analysis cameras. They will walk across a 10 meter runway six times in their conventional socket and six times in the test socket to determine average walking speed.

  2 months

• PedsQL

  quality of life survey for children

  2 months

• CAPP-PSI

  brief, parent-administered inventory for the assessment of prosthesis satisfaction in children with limb deficiency.

  2 months

Study Arms (2)

Phase II

EXPERIMENTAL

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.

Device: iFIT prosthesis

Phase I

EXPERIMENTAL

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.

Device: iFIT prosthesis

Interventions

iFIT prosthesis DEVICE

An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.

Phase I; Phase II

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Four months post-amputation
• Intact, protective sensation in their residual limbs.

You may not qualify if:

• open skin lesions
• excessive pain in the residual limb (phantom pain, residual limb pain, or neuroma)
• neurological disorders (e.g., stroke, severe polyneuropathy) causing weakness in the contralateral leg or marked gait impairment
• inability to follow instructions for trial

Sponsors & Collaborators

• University of Pennsylvania: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (2)

• McCloskey C, Kenia J, Shofer F, Marschalek J, Dillingham T. Improved Self-Reported Comfort, Stability, and Limb Temperature Regulation with an Immediate Fit, Adjustable Transtibial Prosthesis. Arch Rehabil Res Clin Transl. 2020 Dec;2(4):100090. doi: 10.1016/j.arrct.2020.100090. Epub 2020 Nov 2.

  PMID: 33381750 BACKGROUND

• Kenia J, Wolf B, Marschalek J, Dillingham T. An Immediate Fit, Adjustable, Modular Prosthetic System for Addressing World-Wide Limb Loss Disability. Arch Rehabil Res Clin Transl. 2021 Mar 15;3(2):100120. doi: 10.1016/j.arrct.2021.100120. eCollection 2021 Jun.

  PMID: 34179756 BACKGROUND

Related Links

• This is the website for the adult adjustable prosthetic system

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Timothy R Dillingham, MS,MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The William J. Erdman II, Professor and Chair

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 8, 2022
• Study Start: August 18, 2022
• Primary Completion: March 7, 2025
• Study Completion (Estimated): January 29, 2027
• Last Updated: February 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)