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Completed
NCT05230004
Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth
Conditions: Limb Deficiencies, Pediatric ALL
Sex: All
Ages: 3 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: University of Pennsylvania
Location: Penn Medicine Rittenhouse Philadelphia Pennsylvania
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.
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
Source: ClinicalTrials.gov (NCT05230004). StuddyBuddy aggregates publicly available trial information.