Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth

Launched by UNIVERSITY OF PENNSYLVANIA · Jan 27, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new type of adjustable prosthetic system designed specifically for children aged 3 to 18 who have lost a limb. The goal is to create a prosthetic that can be easily adjusted as the child grows, making it more comfortable and usable for them. In the first part of the study, researchers will test the prototype in a lab setting with children who have experienced limb loss. In the second part, participants will use the prosthetic at home for two months to see how well it fits and how comfortable it is.

To be eligible for this trial, children must be at least four months post-amputation and have intact sensation in their remaining limb. They can participate regardless of how they lost their limb, whether from an accident, a birth defect, or health issues. However, those with open wounds, significant pain, certain neurological conditions, or who may have trouble following instructions will not be included. Participants will be asked to complete questionnaires and undergo tests to measure comfort and walking patterns, helping researchers gather valuable information about the prosthetic's performance.

Gender

ALL

Eligibility criteria

• 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