Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth
Study Details
Study Description
Brief Summary
An immediate fit adjustable prosthetic system is being investigated for children. The age range being recruited is from 3 years up to 12 years old. Phase I of this study will involve developing a final prototype by conducting in-lab testing on children with limb loss. A questionnaire, socket pressure measures and biomechanical gait analysis will be conducted.
The aim is to develop appropriate sizes of the prosthetic and arrive at a final design.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
A gait biomechanical 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 walk-way while being recorded by the motion analysis system. This will be conducted in both the test 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 30 seconds. This will be completed on both the test and conventional socket.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Phase I Phase I involves testing the comfort and feasibility of our adjustable prosthetic system for children. This arm will involve in-lab testing only to arrive at a final design. Feedback will be obtained verbally and through the PEQ questionnaire to determine comfort, stability and feasibility of the adjustable system. |
Device: iFIT prosthesis
An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
Outcome Measures
Primary Outcome Measures
- Modified Prosthetic Evaluation Questionnaire [1 day]
Evaluation questionnaire for prosthesis. Questions selected from PEQ are rated from 1-poor, to 5 excellent. 70 points total
- Internal Socket Pressures [1 day]
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.
- Socket Comfort Score [1 day]
Rating of socket comfort from 0 very uncomfortable to 10 very comfortable
- Gait Speed [1 day]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Four months post-amputation
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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.
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Intact, protective sensation in their residual limbs.
Exclusion Criteria:
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open skin lesions
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excessive pain in the residual limb (phantom pain, residual limb pain, or neuroma)
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neurological disorders (e.g., stroke, severe polyneuropathy) causing weakness in the contralateral leg or marked gait impairment
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inability to follow instructions for trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Penn Medicine Rittenhouse | Philadelphia | Pennsylvania | United States | 19146 |
Sponsors and Collaborators
- University of Pennsylvania
- Children's Hospital of Philadelphia
Investigators
- Principal Investigator: Timothy R Dillingham, MS,MD, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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). pii: 100090. doi: 10.1016/j.arrct.2020.100090. Epub 2020 Nov 2.
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