An interventional study of Rebound ACL brace and physioterapy and Physioterapy in Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament Tear, sponsored by Frida Hansson, MD. Terminated at 1 site in Sweden. Open to participants aged Up to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Frida Hansson, MD · Not applicable, Interventional, and Treatment
This study evaluates the use of a brace in acute anterior cruciate ligament (ACL) injuries in children and adolescents. Half of the participants will receive a so called rebound ACL brace together with a standardized rehab program supervised by a physiotherapist, while the other half will receive only the standardized rehab program supervised by a physiotherapist
A well known treatment of posterior cruciate ligament injuries in the acute phase is a brace which pushes the tibia anteriorly, and the result of the treatment is often successful with healing of the ligament. Similarly, in anterior cruciate ligament injuries, it is suggested that a rebound ACL brace which pushes the tibia posteriorly can facilitate healing of the ACL. It does not have as successful treatment results as the PCL brace, but the type and location of the ACL injury has in previous studies not been well defined. We will, after having described the localisation and type of ACL injury treat the intervention group with the rebound ACL brace and a standardized rehab program and the control group with standardized rehab program alone.
The randomization is made blockwise of 4, to treatment A= Brace+physiotherapy or B=Physioterapy. The groups are stratified for gender and age (\<=14 years and >14 years)
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 44 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →This is the only study on the registry with Frida Hansson, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention will be the use of rebound ACL brace for 9 weeks, which initially is locked followed by a gradually increased range of motion. A standardized rehab protocol is applied.
Other: Rebound ACL brace and physioterapy
A standardized rehab protocol comparable to the experimental group but with no brace
Other: Physioterapy
Usage of rebound ACL brace and physioterapy supervised by physioterapist
Physioterapy supervised by physioterapist
Objective knee function
laxity measurement (KT-1000)
Time frame: 6 months
Objective knee function
laxity measurement (KT-1000)
Time frame: 12 months
Objective knee function
laxity measurement (KT-1000)
Time frame: 24 months
objective knee function
muscle strength (measured by Biodex)
Time frame: 6 months
objective knee function
muscle strength (measured by Biodex)
Time frame: 12 months
objective knee function
muscle strength (measured by Biodex)
Time frame: 24 months
objective knee function
jump tests
Time frame: 6 months
objective knee function
jump tests
Time frame: 12 months
objective knee function
jump tests
Time frame: 24 months
Subjective knee function
EQ-5D-Y
Time frame: 6, 12 and 24 months
Subjective knee function
The Knee injury and Osteoarthritis Outcome Score for children, KOOS child. 5 subscales, where each subscale's points are calculated to a scale from 0-100; zero representing extreme knee problems and 100 representing no knee problems
Time frame: 6, 12 and 24 months
Activity level
Presented as Tegner activity scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Time frame: 6, 12 and 24 months
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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