|- candidate number||7854|
|- NTR Number||NTR2250|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-mrt-2010|
|- Secondary IDs||2009-142 METC UMC Groningen|
|- Public Title||Design of a randomized controlled ACL injury prevention study.|
|- Scientific Title||Design of a randomized controlled ACL injury prevention study.|
|- hypothesis||The implicit learning group will show better retention compared to the explicit learning group.|
|- Healt Condition(s) or Problem(s) studied||Prevention, Anterior cruciate ligament (ACL) injury|
|- Inclusion criteria||1. 18 years or older;|
2. Playing basketball at the highest recreational level;
3. No history of major lower extremity injury or surgery;
4. No current or recent (6 months) injury to the entire lower extremity;
5. Able to participate in training and games for 100% at time of testing.
|- Exclusion criteria||1. Any hip, knee or other relevant injury in the last 6 months prior to testing;|
2. Any relevant previous injury or surgery at any joint of the lower extremity;
3. Any history of neurological, vestibular or visual impairment.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2010|
|- planned closingdate||31-mei-2011|
|- Target number of participants||90|
|- Interventions||Two types of immediate feedback will be given:|
Explicit feedback: After performing the sidestep cutting manoeuvres, subjects will immediately receive explicit instructions to improve their performance. Potential ACL injury risk factors include:
1. Increased knee valgus angle;
2. Decreased knee flexion angle;
3. Increased anterior tibial shear force;
4. Decreased hip flexion angle;
5. Increased hip internal rotation angle;
6. Increased knee internal rotation angle.
Items to improve these potential risk factors above will be mentioned to the subjects and subjects will be requested to minimise the load at the knee.
Implicit feedback: Subjects will undergo a dynamic visual feedback intervention. Each time after a subject has performed the task, a visual representation of the best performance so far of the whole body (3D posterior view) will be shown to the subject with the Basler recordings (Darwinian learning). No feedback or instructions at all will be given, however subjects will know in advance that there are superior and inferior ways to perform the task. The subject will search by him-/herself for the solution that fits best in their body; they explore and then select the performance which fits best.
|- Primary outcome||The primary outcome measurements will be as follows:|
1. Average EMG pattern of the gluteus maximus (GM), vastus medialis (VM), vastus lateralis (VL), medial hamstring (MH), lateral hamstring (LH), medial gastrocnemius (MG) and lateral gastrocnemius (LG);
2. Muscle onset time (ie. the first burst in EMG as detected by the Santello algoritm prior to landing ) of the GM, VM, VL, MH, LH, MG and LG;
3. Muscle activity of the GM, VM, VL, MH, LH, MG and LG integrated over the interval from 100 milliseconds prior to foot contact to foot contact (preparatory interval) and from foot contact to the point of peak knee flexion (weight acceptance);
4. Muscle co-contraction (ie. using the integrated EMG of each muscle and the formula: [(less active muscle/more active muscle) X (sum of the integrated activity of both muscles)]73) of VL-MG, VL-LH, VM-LG and VM-MH over the interval from 100 milliseconds prior to foot contact to foot contact (preparatory interval) and from foot contact to the point of peak knee flexion (weight acceptance);
5. Hip, knee and ankle angles at IC, peak posterior GRF and the maximum values for each of those variables:
A. Abduction / adduction;
B. Flexion / extension;
C. External / internal rotation (only for hip and knee);
D. Knee angular displacement flexion angle.
6. Joint moments of hip, knee and ankle at IC, peak posterior GRF and the maximum values for each of those variables:
A. Abduction / adduction;
B. Flexion / extension;
C. External / internal rotation (only for hip and knee).
7. Peak vertical GRF (normalized to body weight);
8. Peak proximal anterior tibial shear force (normalized to body weight).
|- Secondary outcome||1. The history on injuries and / or surgeries;|
2. The Tegner activity level questionnaire;
3. Activity between intervention and follow up tests.
|- Timepoints||To, 1 week post intervention (retention test 1 (t1)) and 1 month post intervention (retention test 2 (t2)).|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MS. PT. Anne Benjaminse|
|- CONTACT for SCIENTIFIC QUERIES||MS. PT. Anne Benjaminse|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), University Center for Sport, Exercise and Health|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||19-mrt-2010 - 29-mrt-2010|