ACTIVE_NOT_RECRUITING

Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth

Quick Facts

Study Start:2022-08-18
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05230004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Four months post-amputation
  2. * 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.
  3. * Intact, protective sensation in their residual limbs.
  1. * open skin lesions
  2. * excessive pain in the residual limb (phantom pain, residual limb pain, or neuroma)
  3. * neurological disorders (e.g., stroke, severe polyneuropathy) causing weakness in the contralateral leg or marked gait impairment
  4. * inability to follow instructions for trial

Contacts and Locations

Principal Investigator

Timothy R Dillingham, MS,MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, 19146
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Timothy R Dillingham, MS,MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-18
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2022-08-18
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • prosthesis
  • limb deficiency
  • limb loss
  • pediatric

Additional Relevant MeSH Terms

  • Limb Deficiencies
  • Pediatric ALL