NCT03336060

Brief Summary

To examine the long-term effects of anterior cruciate ligament injuries and reconstructions (after successful rehabilitation) on cortical processes of motor planning during complex jump landing tasks and the relevance of cognitive performance measures for landing stability, respectively knee injury risk.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

October 27, 2017

Last Update Submit

March 14, 2018

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (3)

  • Bereitschaftspotential - Movement planning associated cortical activity measures

    Determined via Electroencephalography as amplitude in microvolt \[μV\] and latency in milliseconds \[ms\] before initiation of jump movement

    Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, low beta-band power, frontal theta-band power) is 4 hours on one day

  • Sensorimotor rhythm (SMR)/ low beta-band power - Movement planning associated cortical activity measures

    Determined via Electroencephalography in microvolt\^2 \[μV²\]

    Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, low beta-band power, frontal theta-band power) is 4 hours on one day

  • Frontal theta-band power - Movement planning associated cortical activity measures

    Determined via Electroencephalography in microvolt\^2 \[μV²\]

    Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, SMR/ low beta-band power, frontal theta-band power) is 4 hours on one day

Secondary Outcomes (19)

  • Peak ground reaction force - Biomechanical outcome measures of single leg jump-landings

    Cross sectional design. Biomechanical outcome measures of single leg jump-landings are assessed simultaneously with primary outcome assessment (during same 4 hours on one day)

  • Time to stabilisation - Biomechanical outcome measures of single leg jump-landings

    Cross sectional design. Biomechanical outcome measures of single leg jump-landings are assessed simultaneously with primary outcome assessment (during same 4 hours on one day)

  • Center of pressure sway - Biomechanical outcome measures of single leg jump-landings

    Cross sectional design. Biomechanical outcome measures of single leg jump-landings are assessed simultaneously with primary outcome assessment (during same 4 hours on one day)

  • Visual perceptual ability - Lower cognitive function

    Cross sectional design. Timeframe for Assessment is 5 minutes (during congnitive function assessment, separate day as primary outcome assessment)

  • Reaction time/ processing speed - Lower cognitive function

    Cross sectional design. Timeframe for Assessment is 10 minutes (during congnitive function assessment, separate day as primary outcome assessment)

  • +14 more secondary outcomes

Study Arms (2)

Healthy Control

Age matched healthy subjects. Inclusion criteria for healthy controls are: male (18 - 40 years, right-handed); sportive (preferably ball game sports, e.g. soccer); no acute injury or life-quality impairing diseases; no medication

Diagnostic Test: Cortical Correlates of Jump Landing Task

Subjects with ACL reconstruction

Unilateral, primary anterior cruciate ligament tear and reconstruction (1 to 10 years ago); no serious concomitant injuries, e.g. "unhappy triad"); no kinesiophobia; symmetric single leg jump performance (\>85 %); male (18 - 40 years, right-handed); sportive (preferably ball game sports, e.g. soccer); no acute injury or life-quality impairing diseases; no medication

Diagnostic Test: Cortical Correlates of Jump Landing Task

Interventions

Cortical Correlates of Jump Landing TaskDIAGNOSTIC_TEST

The study participants perform counter-movement jumps (CMJ, flight time approximately 500 ms) followed by single leg landings. While under an anticipated condition, the individuals receive the visual information (presented on a screen) on which leg/ foot (left, right) they are required to land before self-initiated CMJs, the individuals will receive this information under the non-anticipated condition only after take-off (approximately 400 ms before ground contact).

Healthy ControlSubjects with ACL reconstruction

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cases: Healthy male participants (18 - 40 lifeyears) with unilateral ACL reconstruction and succesfull rehabilitation Controls: Healthy male participants (18 - 40 lifeyears)

You may qualify if:

  • male (18 - 40 years, right-handed)
  • sportive (preferably ball game sports, e.g. soccer)
  • Only cases:
  • unilateral, primary anterior cruciate ligament tear and reconstruction (1-10yrs ago)
  • no serious concomitant injuries (e.g. "unhappy triad")
  • no kinesiophobia
  • symmetric single leg jump performance (\>85 %)

You may not qualify if:

  • acute injury or life-quality impairing diseases
  • any medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goethe University Department of Sports Medicine

Frankfurt am Main, Hesse, 60487, Germany

RECRUITING

Related Publications (1)

  • Giesche F, Engeroff T, Wilke J, Niederer D, Vogt L, Banzer W. Neurophysiological correlates of motor planning and movement initiation in ACL-reconstructed individuals: a case-control study. BMJ Open. 2018 Sep 19;8(9):e023048. doi: 10.1136/bmjopen-2018-023048.

    PMID: 30232114DERIVED

Study Officials

  • Winfried Banzer, Prof

    Head of Department; Goethe University Department of Sports Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Winfried Banzer, Prof

CONTACT

06979824482Banzer@sport.uni-frankfurt.de

Florian Giesche, M.Sc.

CONTACT

06979824482Giesche@sport.uni-frankfurt.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department, Dpt. Sports Medicine

Study Record Dates

First Submitted

October 27, 2017

First Posted

November 8, 2017

Study Start

October 1, 2017

Primary Completion

May 31, 2018

Study Completion

June 30, 2018

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

DE(1)