Status:
ACTIVE_NOT_RECRUITING
Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Children's Hospital of Philadelphia
Conditions:
Limb Deficiencies
Pediatric ALL
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief 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 fina...
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 surve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05230004
Start Date
August 18 2022
End Date
December 30 2025
Last Update
October 22 2025
Active Locations (1)
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1
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, United States, 19146