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

Phase 2

Completed

Conditions: Neural plasticity/Changes in brain activation pattern
10043237

Registration Number: NL-OMON43257

Lead Sponsor: Ziekenhuisgroep Twente

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 27

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is the difference in EEG Theta activity<br /><br>during the force-reproduction task between the ACL deficient group, the ACL<br /><br>reconstructed group and the healthy controls. The Theta-power consists of all<br /><br>waves in the frequency spectrum between 4.75 Hz en 6.75 Hz in the repetition<br /><br>period (where no visual feedback is present) in both measurement blocks (B1 and<br /><br>B2). Thereafter, a logarithmic transformation of the power values is done to<br /><br>stabilize the power values for the statistical analysis. The stabilized<br /><br>Theta-value (of blocks B1 and B2) are then compared between the ACL deficient<br /><br>patients, ACL reconstructed patients and the healthy controls. </p><br>

Secondary Outcome Measures