Adjustable prosthetic systems for children with limb loss
Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth
NA · University of Pennsylvania · NCT05230004
This study is testing a new adjustable prosthetic system for kids aged 3 to 18 with limb loss to see how well it fits and works for them as they grow.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05230004 on ClinicalTrials.gov |
What this trial studies
This study investigates an innovative adjustable prosthetic system designed for children aged 3 to 18 who have experienced limb loss. The research is divided into two phases: Phase I focuses on in-lab testing of prototype designs, gathering feedback from participants to refine the prosthesis, while Phase II involves a two-month home trial to assess comfort and usability. Participants will provide feedback through questionnaires and gait analysis to evaluate the effectiveness of the prosthesis. The goal is to create a prosthetic solution that accommodates the growth and changing needs of pediatric patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 18 who are four months post-amputation and have intact protective sensation in their residual limbs.
Not a fit: Patients with open skin lesions, excessive pain in the residual limb, or neurological disorders affecting gait may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and comfortable prosthetic solutions for children, enhancing their mobility and quality of life.
How similar studies have performed: Other studies have shown promise in developing adjustable prosthetic systems for pediatric patients, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Penn Medicine Rittenhouse — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Timothy R Dillingham, MS,MD — University of Pennsylvania
- Study coordinator: Jessica L Kenia, MS
- Email: jessica.kenia@pennmedicine.upenn.edu
- Phone: 215-893-2678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Limb Deficiencies, Pediatric ALL, prosthesis, limb deficiency, limb loss, pediatric