Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth

Completed · Not applicable

Conditions studied: Limb Deficiencies, Pediatric ALL

In brief

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.

Key facts

Study ID

NCT05230004

Run by

University of Pennsylvania

People needed

35

Starts

2022-08-18

Expected to finish

2026-06-02

Last updated by the study team

2026-07-02

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Penn Medicine Rittenhouse — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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