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NCT05230004 · ClinicalTrials.gov registry record · NA
Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth
A NA study of Pediatric ALL and Limb Deficiencies, sponsored by University of Pennsylvania.
- Active
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT05230004: Active NA study of Pediatric ALL and Limb Deficiencies, sponsored by University of Pennsylvania.
NCT05230004 is a NA study of Pediatric ALL and Limb Deficiencies that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 28 participants, below the 1,647-participant average among 21 other Pediatric ALL trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05230004, a NA study of Pediatric ALL and Limb Deficiencies, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
12 questions selected from the Prosthetic Evaluation Questionnaire were used to rate the prosthesis on comfort, stability, and utility. The questions featured a rating scale from 1-poor to 5-excellent. The range for scores is 12 to 60 total points. Higher scores are considered better.
Conditions Studied
Interventions
- DEVICE iFIT prosthesis
Study Locations (1)
Pennsylvania
- Penn Medicine Rittenhouse - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-08-18 |
| Est. Completion | 2027-01-29 |
| Phase | NA |
What the registry record for NCT05230004 still lists
NCT05230004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,647-participant average among 21 other Pediatric ALL trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Pediatric ALL appearing as the primary indexed condition, and to 1 intervention - of which iFIT prosthesis is the first listed.
NCT05230004 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05230004 about?
NCT05230004 is a clinical study titled "Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth". 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 mon...
What is the current status of trial NCT05230004?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 28 participants. The study started on 2022-08-18. Estimated completion is 2027-01-29.
What conditions does trial NCT05230004 study?
This clinical trial studies the following conditions: Pediatric ALL, Limb Deficiencies.
What interventions are being tested in trial NCT05230004?
The interventions under investigation include: iFIT prosthesis (DEVICE).
Who is sponsoring clinical trial NCT05230004?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05230004 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05230004's enrollment target sits among peer trials
28 19th of 21 higher than 3 of 21 other Pediatric ALL trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pediatric ALL trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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