- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06192134
Continuous Passive Motion Device for Children With Arthrogryposis
June 28, 2024 updated by: Tariq Rahman, Nemours Children's Clinic
The Investigators are investigating a continuous passive motion device to exercise the knee of young children with arthrogryposis after they have had knee surgery.
Study Overview
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 Type
Interventional
Enrollment (Estimated)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tariq Rahman
- Phone Number: 302 651 6831
- Email: trahman@nemours.org
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.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Children with arthrogryposis
- Children between 3 and 7 years of age
- Children who have had recent knee surgery
Exclusion Criteria:
- Children older than 7
- Children unable to cooperate with protocol steps
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CPM group
group receiving CPM therapy
|
CPM brace
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
range of motion
Time Frame: 2 weeks
|
knee range of motion
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Estimated)
January 1, 2025
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
December 20, 2023
First Submitted That Met QC Criteria
December 20, 2023
First Posted (Actual)
January 5, 2024
Study Record Updates
Last Update Posted (Estimated)
July 1, 2024
Last Update Submitted That Met QC Criteria
June 28, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1798457
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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