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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05230004). StuddyBuddy aggregates publicly available trial information.