Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06192134
Other study ID # 1798457
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date June 2026

Study information

Verified date June 2024
Source Nemours Children's Clinic
Contact Tariq Rahman
Phone 302 651 6831
Email trahman@nemours.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 5
Est. completion date June 2026
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 3 Years to 7 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
CPM device
CPM brace

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nemours Children's Clinic

Outcome

Type Measure Description Time frame Safety issue
Primary range of motion knee range of motion 2 weeks
See also
  Status Clinical Trial Phase
Completed NCT01028833 - Effects of Power Mobility on Young Children With Severe Motor Impairments Phase 2
Withdrawn NCT01306994 - Study of Resting and Exercising Body Functioning in Freeman-Sheldon Syndrome and Related Conditions
Completed NCT02218593 - WREX Outcome Study
Terminated NCT01307475 - Study of Quality of Life in Freeman-Sheldon Syndrome and Related Conditions N/A
Terminated NCT01144741 - Survey Study and Records Review of Treatment Outcomes in Freeman-Sheldon Syndrome
Enrolling by invitation NCT04789746 - Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges N/A
Recruiting NCT04798378 - NuroSleeve Powered Brace & Stimulation System to Restore Arm Function N/A