Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth

Pediatric ALL Clinical Trial

Official title:

Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230004
• Other study ID #: 849980
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: University of Pennsylvania
• Contact: Jessica L Kenia, MS
• Phone: 215-893-2678
• Email: jessica.kenia[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Design Phase I is a testing session to obtain feedback on initial prototype designs for the immediate fit prostheses. This research will focus on PI observations and participant feedback through survey and comments during the in-person testing. There may be multiple appointments for participants during this time the device design is refined. In-lab testing only will occur. This information will influence the overall design of the final prosthesis.

PHASE I: For Phase I children with lower limb limb loss (below the knee or above the knee) age 3-12 are being recruited. Subjects should be able to ambulate with or without assistive devices. They will supply measurements and limb images prior to the appointment.

During the initial appointment, each participant will be consented and completed roughly 2-3 hours of device testing. The participant will be fit with an adjustable prosthetic by the PI. After ambulating in the lab, they will give feedback on the comfort, stability and ease of use of the prosthesis. Participants may be asked to return several times for future testing sessions once changes or alterations are made to the prosthesis design to see if these have been effective. The child and their parent will fill out a PEQ based questionnaire on their conventional prosthesis and the investigational device after fitting.

Phase II: We will be recruiting children ages 3-18 with lower limb loss to be with an adjustable prosthesis and wear it for a 2 month home trial. Children may be recruited at other locations such as the Children's Hospital of Philadelphia and Ai./duPont Nemours in Delaware. The child and their parent will fill out questionnaires on their current prosthesis as well as have pressure data and a gait analysis completed. Once they have worn the prosthesis for 2 months they will return and complete these same outcome measures.

Gait biomechanical analysis: This analysis will be conducted by having several reflective markers placed on the participant's lower body. The subject will then walk a minimum of 6 times along a 10meter walkway while being recorded by the motion analysis system. This will be conducted in both the adjustable and conventional prosthesis.

Internal pressure measurements of the socket using Fujifilm pressure paper will also be obtained. Five spots will be assessed by placing the paper on the participant's liner and then they will put on their socket and walk for 1 minute. This will be completed on both the test and conventional socket.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• Four months post-amputation

• Subjects who have lost a limb due to any cause: trauma, congenital limb loss, dysvascular causes (peripheral vascular disease and diabetes), or malignancy will all be eligible for inclusion.

• Intact, protective sensation in their residual limbs.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Limb Deficiencies
• Pediatric ALL

Intervention

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

Locations

Country	Name	City	State
United States	Penn Medicine Rittenhouse	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Socket Comfort Score	Rating of socket comfort from 0 very uncomfortable to 10 very comfortable	2 months
Primary	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
Primary	PedsQL	quality of life survey for children	2 months
Primary	CAPP-PSI	brief, parent-administered inventory for the assessment of prosthesis satisfaction in children with limb deficiency.	2 months

External Links

•   This is the website for the adult adjustable prosthetic system