Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04838158 |
Other study ID # |
PolishMMHRI 23/06/2010 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 10, 2015 |
Est. completion date |
January 30, 2016 |
Study information
Verified date |
January 2021 |
Source |
Polish Mother Memorial Hospital Research Institute |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The study enrolled 33 patients with confirmed recurrent patellar dislocation, including 6
patients with bilateral involvement. In the study group, both side hamstring muscle were
evaluated at the velocities of 60 and 180 deg/s for the following parameters: peak torque,
torque in 30 degree of the knee flexion, angle of peak torque and peak torque hamstring to
quadriceps ratio (H/Q ratio).
Description:
The study enrolled 33 patients with confirmed recurrent patellar dislocation, including 6
patients with bilateral involvement. The study group consisted of 20 girls and 13 boys with
average age at the time of the study 16.2 years (range: 8 to 17 years, SD 2.7). For the
purpose of the study, a control group of 18 healthy subjects (12 girls and 6 boys) aged on
the average 15.7 years (range:13 to 17 years, SD 1.5), was recruited.
The following study inclusion criteria were applied: recurrent patellar dislocation,
correctly completed testing protocol, age under 18 years at the time of testing. Subjects
with osteochondral fracture and those with a history of the knee surgery were excluded.
Each patient underwent an isokinetic examination on Biodex System 3 (Biodex Multi-Joint
System - Pro, Biodex Medical Systems, Inc. New York, USA). In the study group, both side
hamstring muscle were evaluated at the velocities of 60 and180 deg/s for the following
parameters: peak torque (PT), torque in 30 degree of the knee flexion (T 30 deg.), angle of
peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio).
Isokinetic measurements were made by a trained, experienced physiotherapist. After a proper
warm-up and instruction, the test performed 10 full repetitions, the best result was
recorded. The results of the peak torque (PT) of both test and control limbs were then
compared with the normative data for age and gender available in the literature. In addition,
we compared the peak torque (PT), torque in 30 degrees of the knee flexion (T 30 deg.), angle
of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio) of involved
and uninvolved knee flexor strength in the study group. Depending on the data distribution,
the nonparametric Wilcoxon's test or the parametric t-test for the related data was applied.
Statistical significance was assumed for p<0.05. The study was approved by our Institutional
Review Board. Informed consent was obtained and the rights of subjects were protected.