Examining the hypothesis that patients with ACL deficiency and patients with ACL reconstructions, despite comparable force-reproduction capacities with the affected, dominant right leg, have a significant altered EEG Theta-activity in the motor…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the difference in EEG Theta activity
during the force-reproduction task between the ACL deficient group, the ACL
reconstructed group and the healthy controls. The Theta-power consists of all
waves in the frequency spectrum between 4.75 Hz en 6.75 Hz in the repetition
period (where no visual feedback is present) in both measurement blocks (B1 and
B2). Thereafter, a logarithmic transformation of the power values is done to
stabilize the power values for the statistical analysis. The stabilized
Theta-value (of blocks B1 and B2) are then compared between the ACL deficient
patients, ACL reconstructed patients and the healthy controls.
Secondary outcome
The differences of (a), (b) and (c) between the ACL deficient group, the ACL
reconstructed group and the healthy controls. The differences are examined
using the main values and standard deviations of all groups:
a. The alpha-2-EEG power (Hz):The alpha-2-power is examined in the same way as
the Theta-power (see primary outcome). With the difference, the alpha-2-power
consists of the frequencies between 9.75Hz and 12.5Hz. The powers of the
alpha-1 (7-9.5Hz), beta-1 (12.75-18.5) can also be obtained in the same way.
b. EMG activity: EMG activity is determined with help of elektrodes at the m.
rectus femoris (RF), m. vastus medialis (VM) and m. vastus lateralis (VL) in
the last millisecond before the maximal angle is reached, because the
quadriceps forces are maximal at this moment.
c. Mean force-reproduction and standard deviations: the mean is calculated by
the maximal force value of every repetition devided by the number of
repetitions in the period without visual feedback (20 repititions)
Besides, the differences of the primary outcome and the outcomes mentioned
above (a), (b) and (c) are determined between the force-reproduction periode
without visual feedback (B1 and B2) and the force-reproduction with additional
feedback (B3 and B4) for the ACL deficient, the ACL reconstucted and the
healthy control group In all cases the differences are compared between groups
using the mean values and the standard deviations
Background summary
Nowadays, the (operative and conservative) treatment and the rehabilitation
after an anterior cruciate ligament (ACL) injury focuses on the restoring of
mechanical stability. However, despite the restored mechanical stability a lot
of patients have re-ruptures or remaining symptoms of instability. A possible
explanation for this large number of re-ruptures is the lack of, or change of,
sensory input from the affected knee. As a result, the central nervous system
receives adjusted information and adapts to the new situation, a process called
neural plasticity.
The biomechanical function of ACL patients is extensively investigated, yet
neural plasticity is hardly studied. Biomechanical research shows that postural
control and landing tasks are executed comparable by ACL patients and healthy
controls with eyes open. However, when eyes are closed the execution is
significantly diminished in ACL patients. This implies the additional need of
visual feedback in ACL patients. Earlier research, which examines the brain
activity in ACL reconstructed and ACL deficient patients, has shown an
increased activation of the visual cortex during simple movements with the
affected leg compared to legs of healthy controls.
Study objective
Examining the hypothesis that patients with ACL deficiency and patients with
ACL reconstructions, despite comparable force-reproduction capacities with the
affected, dominant right leg, have a significant altered EEG Theta-activity
in the motor cortex during a repetitive force-reproduction task compared to the
dominant right leg of the healthy controls.
Study design
A cross-sectional, three-armed case-control study, consisting of twelve healthy
controls, twelve ACL deficient patients and twelve ACL reconstructed patients.
Study burden and risks
Participation to this research takes sixty minutes of the subject*s time, in
addition to the regular care. This is considered to be a small load to the
patient, especially because the appointment can be coupled to an existing
appointment (if applicable) and otherwise can be planned at a time of choice of
the patient (potentially in the evenings). Participation in this research has
no consequences for the regular care of the patient.
Geerdinksweg 141
Hengelo 7555DL
NL
Geerdinksweg 141
Hengelo 7555DL
NL
Listed location countries
Age
Inclusion criteria
General inclusion criteria:
- Tegnerscore > 4
- Age between 18 and 30 years at the moment of inclusion
- The right leg is the dominant leg;Additional inclusion criteria ACL reconstruction group:
- primary ACL reconstruction
- Date of measurement and date of reconstruction are not less than nine months but not more than fifteen months from each other.
- Date of rupture and date of reconstruction surgery are not more than five months from each other.;Additional inclusion criteria ACL deficient group:
- Date of measurement and date of rupture are not less than seven months but not more than seventeen months from each other. ;Additional inclusion criteria control group:
- No knee damage (bilateral) in history
- No physical limitations at the moment of measurement
Exclusion criteria
- Complications during rehabilitation (re-ruptures, additional knee damage and/or no (expected) functional recovery after 12 months
- Epilepsy and/or other brain diseases
- Pregnancy;Additional for the ACL reconstructed and ACL deficient groups:
- Additional ligament injury at the moment of ACL rupture
- ACL deficiency or ACL reconstruction at the contralateral knee
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL59713.044.16 |
| Other | nog niet bekend (volgt binnen 4 weken) |
| OMON | NL-OMON27640 |