ACL injury / knee ligament rupture ACL injury
Conditions
Interventions
Multiple sessions of BioStim-driven FES per week from the point of entry into the study to its end, 12 weeks later. Each individual session takes place in the clinic, lasts for 15min and is composed o
Sponsors
Technische Universiteit Delft, Faculty of Mechanical Engineering
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients who have suffered an ACL injury, undergone subsequent surgical reconstruction of the ligament, and are currently undergoing rehabilitation at the KNVB medical center in Zeist Patients over 18 years old and under 64 years old High-level athletes, as defined by having a pre-injury Tegner Activity Scale (TAS) of 7, 8, 9 or 10, aiming to return to a pre-injury level of activity Patients capable of full weight bearing, as deemed by the physiotherapist team
Exclusion criteria
Exclusion criteria: Patients who are pregnant Patients who are using another personal medical electrical equipment (including but not limited pacemakers and insulin pumps) Patients who have been treated conservatively for their ACL injury Patients who have a concurrent injury to their contralateral side that is severe enough to the point of impairing their mobility Patients who are unable to walk whilst fully supporting their own weight within 8 weeks of the surgery (which would likely be the reflection of a significantly disturbed early phase of their rehabilitation) Patients who have been undergoing rehabilitation for more than two weeks at the time of study commencement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter and outcome is the maximum voluntary normalized muscle strength of the knee extensors and flexors on the ACL-injured side. Strength will be measured isometrically at multiple time points throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following outcome measures will also be evaluated at regular intervals during the study to obtain a comprehensive picture of the objective and subjective impact of the device on patients:· Change in the score of the International Knee Documentation Committee Subjective Form (IKDC-SF) over time. The IKDC-SF is a widely used, self-administered questionnaire assessing subjective knee function after trauma.· Assessment of pain and swelling/effusion· Psychological evaluation· Functional movement assessment using motion captureIn the long term, data on return to sport and re-injury rates will also be assessed. | — |
Countries
Netherlands
Contacts
Public ContactE. van der Kruk
Technische Universiteit Delft
Outcome results
None listed