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Completed

NCT Number: NCT03132987

Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction

Quantify differences in quadriceps function and gait biomechanics in individuals within 2 years of ACL reconstruction compared to a healthy comparison group and establish the feasibility of conducting a progressive strengthening program to improve clinical and patient-oriented outcomes in individuals who are within 2 years of ACL reconstruction

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Key information

Conditions

ACL Tears Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

14 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Creighton University

Omaha, Nebraska, 68178, United States

About this study

A maximal isometric muscle contraction of the quadriceps will be used to examine neural and peripheral contributions to quadriceps strength. Neural influences will be quantified using the interpolated twitch technique (voluntary activation) and early RTD. Peripheral influences will be quantified by examining the stimulus-evoked torque with the quadriceps relaxed (resting twitch) and late RTD. Knee joint biomechanics during treadmill walking and running will include sagittal plane (flexion, extension) movement variability (Lyapunov Exponent and approximate entropy), peak knee flexion angle, and peak external knee flexion and adduction moments. Additionally, the clinical relevance of impairments in the ACL reconstruction group will be determined by examining the relationship with performance on jumping tasks and patient function (secondary outcomes).

The progressive strengthening program will be performed for 6 weeks and emphasize development of strength and power. Feasibility will be established if the researchers can recruit up to 8 participants and retain at least 80% over the 3 week intervention program. The researchers will determine effect sizes for changes outcome measures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physically active
  • History of primary unilateral ACL reconstruction within the past 3-24 months (ACL group only)

Exclusion criteria

  • History of lumbar spine or lower extremity injury or surgery (except ACL) within the past 1 year that required physician care
  • Concomitant knee injury (ACL group only): ligament injury that requires surgical repair (medial collateral ligament [MCL], posterior cruciate ligament[PCL]), chondral defects >2cm, fracture, bilateral knee injury
  • Medial conditions that are contraindications to electrical stimulation: Cardiac Pacemaker and Pregnancy
  • Participants who are unable to understand procedures of experiment or provide consent (assent/parental permission)

Treatment and study plan

Progressive strengthening program

Other

The progressive strengthening program will be performed for 3 weeks and emphasize development of strength and power. Feasibility will be established if we can recruit up to 8 participants and retain at least 80% over the 3 week intervention program. We will determine effect sizes for changes outcome measures.

Primary outcomes

  1. Quadriceps Rate of Torque Development (RTD) Maximum

    Time frame: Change from Baseline Quadriceps RTD at 3 weeks

    slope of the torque-time tracing (change in torque/change in time) (Nm/kg*s-1)

  2. Knee Joint biomechanics during gait (nonlinear)

    Time frame: Change from Baseline nonlinear knee joint biomechanics at 3 weeks

    Sagittal plane (knee flexion) movement variability (calculated using Lyapunov Exponent and approximate entropy)

Secondary outcomes

  1. Quadriceps percent activation

    Time frame: Change from Baseline Quadriceps percent activation at 3 weeks

    Supramaximal electrical stimulus (interpolated twitch technique) used to augment a voluntary muscle contraction

  2. Knee Joint biomechanics during gait (traditional)

    Time frame: Change from Baseline knee joint biomechanics at 3 weeks

    peak external knee flexion moment (Nm/kgm)

  3. Patient reported function

    Time frame: Change from Baseline IKDC at 3 weeks

    International Knee Documentation Committee (IKDC) subjective form

  4. Jumping performance

    Time frame: Change from Baseline single leg hop for distance at 3 weeks

    single leg hop for distance (cm)

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)
  • National Institutes of Health (NIH)
  • University of Nebraska

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2017
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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