Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 9:59 AM
Study NCT ID:
NCT06192134
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2023-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Passive Motion Device for Children With Arthrogryposis
Sponsor:
Nemours Children's Clinic
Organization:
Study Overview
Official Title:
Continuous Passive Motion Device for Children With Arthrogryposis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Investigators are investigating a continuous passive motion device to exercise the knee of young children with arthrogryposis after they have had knee surgery.
Detailed Description:
The investigators will measure the effect of continuous passive motion (CPM) of the knee joint post-surgery on young children with arthrogryposis. The investigators have developed a motorized brace that will move the joint through a prescribed range of motion and speed while the subject is seated. The objective of this pilot study is to develop the device from subject feedback and determine the right dose and speed of CPM to provide. CPM is routinely used for adults and older children after surgery to maintain range of motion. The machines used are too large for young children therefore the investigators have developed a prototype for small sized kids that will exercise their knee joint post-surgery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: