Clinical trial · Interventional
Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth
NCT05230004CI-TRIAL-00116627completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Limb Deficiencies | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iFIT prosthesis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase II
- description
- Phase II involves a two month home trial to determine the comfort and utility of an adjustable prosthetic system for children. Children will be fit at several different locations by their prosthetist with the adjustable socket. They will complete several questionnaires on their current device, as well as have internal socket pressures and a gait analysis completed. They will return one month later to complete the same outcome measures on their conventional device. They will also be given activity monitors to track their activity through the duration of the project.
- interventionNames
- Device: iFIT prosthesis
- type
- EXPERIMENTAL
- label
- Phase I
- description
- Phase I involves developing a final design for an adjustable, immediate fit prosthesis. We will recruit 5-10 participants age 3-12 to complete in-lab testing and evaluation of several designs. This testing will lead to the final product design to be tested in Phase II.
- interventionNames
- Device: iFIT prosthesis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDMcCloskey C, Kenia J, Shofer F, Marschalek J, Dillingham T. Improved Self-Reported Comfort, Stability, and Limb Temperature Regulation with an Immediate Fit, Adjustable Transtibial Prosthesis. Arch Rehabil Res Clin Transl. 2020 Dec;2(4):100090. doi: 10.1016/j.arrct.2020.100090. Epub 2020 Nov 2. PMID 33381750
- BACKGROUNDKenia J, Wolf B, Marschalek J, Dillingham T. An Immediate Fit, Adjustable, Modular Prosthetic System for Addressing World-Wide Limb Loss Disability. Arch Rehabil Res Clin Transl. 2021 Mar 15;3(2):100120. doi: 10.1016/j.arrct.2021.100120. eCollection 2021 Jun. PMID 34179756