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Electrocortical activity during force control movements in patients with anterior cruciate ligament (ACL) reconstructions versus patients with ACL deficiency versus healthy controls.

Electrocortical activity during force control movements in patients with anterior cruciate ligament (ACL) reconstructions versus patients with ACL deficiency versus healthy controls. - Electrocortical Activity in Patients with ACL ruptures

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43257
Enrollment
36
Registered
2017-01-19
Start date
2017-02-07
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neural plasticity/Changes in brain activation pattern

Interventions

None listed

Sponsors

Ziekenhuisgroep Twente
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)